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Sun Y, Zhu M, Qiu L. Efficacy of mesenchymal stem cells and platelet-rich plasma therapies on wound healing: A Systematic Review and meta-analysis. Regen Ther 2025; 30:75-91. [PMID: 40491558 PMCID: PMC12148411 DOI: 10.1016/j.reth.2025.04.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2025] [Revised: 04/02/2025] [Accepted: 04/17/2025] [Indexed: 06/11/2025] Open
Abstract
Background Wound healing is a complex physiological process essential for maintaining tissue integrity and function. This meta-analysis aims to evaluate the efficacy of mesenchymal stem cells (MSCs) and platelet-rich plasma (PRP), and their combination in enhancing wound healing. Methods We conducted a systematic search of PubMed, Web of Science, and Scopus databases for studies published from 2010 to 2024. The inclusion criteria were randomized controlled trials (RCTs) and controlled clinical trials involving human subjects treated with MSCs, PRP, or both. The primary outcomes assessed were wound closure rates and mean healing times, while secondary outcomes included wound size reduction, pain management, infection rates, recurrence, adverse events, and cost-effectiveness. Data were pooled using STATA software version 17.0, with standardized mean differences (SMDs) and risk differences (RDs) calculated. Results A total of 34 studies involving 2458 patients were included. PRP and MSCs significantly reduced wound healing time (PRP: SMD = -1.08, 95 % CI: 1.75 to -0.42, p < 0.001; MSCs: SMD = -1.7195 %, CI: 2.44 to -0.99, p < 0.001). MSCs positively impacted new vessel development (overall SMD = 0.55, 95 % CI: 0.39 to 0.71, p < 0.001). PRP-treated groups had higher ulcer healing rates (72.4 % vs 52.5 %, RD = 0.21, 95 % CI: 0.16 to 0.26, p < 0.001). Infection rates showed no statistically significant difference between PRP and control groups (DR = -0.11, 95 % CI: 0.34 to 0.12, p > 0.05), while rest pain scores were significantly lower in PRP-treated patients (SMD = -4.69, 95 % CI: 0.87 to -0.62, p = 0.02). PRP-treated ulcers had lower recurrence rates (RD = -0.14, 95 % CI: 0.75 to 0.97, p = 0.01). Conclusions The findings from this meta-analysis underscore the promising potential of PRP and MSCs as effective therapeutic strategies for wound healing when used individually.
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Affiliation(s)
- Yunqing Sun
- Department of Pediatrics, Shandong Provincial Third Hospital, Shandong University, No.11 Wuyingshan Middle Road, Tianqiao District, Jinan, Shandong, 250031, China
| | - Ming Zhu
- Department of Pediatrics, Shandong Provincial Third Hospital, Shandong University, No.11 Wuyingshan Middle Road, Tianqiao District, Jinan, Shandong, 250031, China
| | - Lianmei Qiu
- Taian Central Blood Station, No. 9, Yingchun Road, Taishan District, Tai'an City, Shandong, 271000, China
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Clavel S, Denizot C, Boëzennec B, Turzi A, Albache N. A Randomised Controlled Clinical Study Comparing the Efficacy and Safety of an Autologous Standardised Leukocyte-Poor Platelet Gel With Standard Care for the Treatment of Chronic Neuropathic Diabetic Foot Ulcers. Int Wound J 2025; 22:e70495. [PMID: 40240289 PMCID: PMC12003047 DOI: 10.1111/iwj.70495] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/01/2024] [Revised: 03/21/2025] [Accepted: 03/26/2025] [Indexed: 04/18/2025] Open
Abstract
This randomised controlled clinical trial compared the efficacy of a standardised autologous platelet gel (RegenWound gel) (n = 48) with a standard care treatment (hydrocellular or hydrocolloid dressing) (n = 48) for the treatment of hard-to-heal foot ulcers in type 1 or 2 diabetes mellitus patients > 18 years old. The primary outcomes were the percentage of ulcers healed 6 weeks after treatment commenced. The secondary outcomes were the average healing time, the time course of the healing process, the local tolerance, and the acceptability of the treatment by the patient compared to the standard treatment. At the 6 weeks end-of-treatment visit (ETV), 56.5% of the patients in the RegenWound gel group and 20.0% of the patients in the control group had completely healed. Healing continued to evolve after the ETV and reached 77.3% at end-of-study visit 2 (12 weeks) in the RegenWound gel group, compared to 35.1% for the control group. The treatment was well tolerated and safe. RegenWound gel could be an effective treatment for diabetic foot ulcers, with most patients being healed within 6 weeks of treatment, and on average 1 to 2 treatments being needed. Trial Registration: ISRCTN10032417.
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Affiliation(s)
- Sylvaine Clavel
- Department of EndocrinologySOS Group–Hotel DieuLe CreusotFrance
| | | | | | | | - Nizar Albache
- Department of EndocrinologySOS Group–Hotel DieuLe CreusotFrance
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Coye TL, Bargas Ochoa M, Zulbaran-Rojas A, Martinez Leal B, Quattas A, Tarricone A, Chung J, Najafi B, Lavery LA. Healing of diabetic neuropathic foot ulcers receiving standard treatment in randomised controlled trials: A random effects meta-analysis. Wound Repair Regen 2025; 33:e13237. [PMID: 39654287 DOI: 10.1111/wrr.13237] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/20/2024] [Revised: 10/21/2024] [Accepted: 11/10/2024] [Indexed: 01/12/2025]
Abstract
This meta-analysis aimed to systematically assess and synthesise healing rates within a 12- to 24-week treatment period among patients with diabetic foot ulcers receiving standard-of-care interventions in randomised controlled trials. This meta-analysis included 32 randomised controlled trials conducted between 1996 and 2023, with sample sizes ranging from 9 to 169 patients. A random-effects model was applied to estimate pooled healing and infection rates. Heterogeneity was quantified using the I2 statistic, and publication bias was assessed using Egger's test. The results revealed a pooled healing rate of 33.15% with a 95% confidence interval (CI) of 31.18%-35.11% and an average healing time of approximately 50.14 days (standard deviation: 31.10 days). The infection proportion was determined to be 17.4% (95% CI: 12.2%-22.5%). Subgroup analysis indicated marginally higher healing rates in the 'Saline Gauze' group compared to the 'Alginate' group, although the latter exhibited a reduced infection proportion. Sensitivity analysis affirmed the robustness of these findings whereas Egger's test suggested the presence of potential publication bias concerning the healing outcomes. The standard-of-care interventions for diabetic foot ulcers demonstrate limited effectiveness, with only about one-third of patients achieving wound closure. The significant heterogeneity and publication bias observed necessitate a cautious interpretation of these results. The findings highlight the need for advanced wound care strategies and personalised treatment plans to improve outcomes in diabetic foot ulcers management. Future research should focus on conducting high-quality, well-reported randomised controlled trials to better understand effective treatments for DFUs.
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Affiliation(s)
- Tyler L Coye
- Michael DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA
| | - Miguel Bargas Ochoa
- Michael DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA
| | | | | | - Abderrahman Quattas
- Michael DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA
| | - Arthur Tarricone
- Department of Orthopedics, University of Texas Health Sciences, Austin, Texas, USA
| | - Jayer Chung
- Michael DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA
| | - Bijan Najafi
- Michael DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA
| | - Lawrence A Lavery
- Department of Plastic Surgery, University of Texas Southwestern, Dallas, Texas, USA
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Monami M, Scatena A, Ragghianti B, Miranda C, Monge L, Silverii A, Uccioli L, Vermigli C. Effectiveness of most common adjuvant wound treatments (skin substitutes, negative pressure wound therapy, hyperbaric oxygen therapy, platelet-rich plasma/fibrin, and growth factors) for the management of hard-to-heal diabetic foot ulcers: a meta-analysis of randomized controlled trials for the development of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome. Acta Diabetol 2024:10.1007/s00592-024-02426-7. [PMID: 39724338 DOI: 10.1007/s00592-024-02426-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2024] [Accepted: 11/23/2024] [Indexed: 12/28/2024]
Abstract
AIM To assess the effects of several adjuvant therapies (AT) commonly used in the treatment of diabetic foot ulcers (DFU). The present meta-analysis was designed to support the development of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome. METHODS A Medline and Embase search were performed up to May 20th, 2024 collecting all RCTs including diabetic patients or reporting subgroup analyses on diabetic patients with DFU comparing AT with placebo/standard of care (SoC), with a duration of at least 12 weeks. Prespecified endpoints were: ulcer healing (principal), time-to-healing, major and minor amputation, serious adverse events (SAE), and all-cause mortality. AT assessed were: growth factors (GF), Platelet-rich plasma and fibrin (PRP/F), skin substitutes (SS), negative pressure wound therapy (NPWT), and hyperbaric oxygen therapy (HBOT). Mantel-Haenzel Odds ratios and 95% confidence intervals (MH-OR, 95% CIs) were either calculated or extracted directly from the publications. Weighted mean differences and 95% CIs were calculated for continuous variables. RESULTS Fifty-one studies fulfilled all inclusion criteria (3, 5, 27, 8, and 8 with GF, PRP/F, SS, NPWT, and HBOT, respectively). Participants treated with any of the explored AT had a significantly higher ulcer healing rate (MH-OR ranging from 2.17 to 4.18) and shorter time-to-healing in comparison with SoC/placebo. Only PRP/F and HBOT showed a significantly lower risk of major amputation (MH-OR: 0.32(0.11;0,93; p = 0.04 and 0.28(0.10;0,79; p = 0.02, respectively), despite a higher risk of SAE. No other significant effects on the above-reported prespecified endpoints were observed. For the primary endpoint, the quality of evidence was rated as "high" for all the AT, except for NPWT ("moderate"). CONCLUSIONS In conclusion, AT can actively promote wound healing and shorten time-to-healing in patients with DFU. HBOT and PRP/F also showed a reduction of the risk of major amputation, despite a higher rate of SAE.
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Affiliation(s)
- Matteo Monami
- Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.
| | - Alessia Scatena
- San Donato Hospital, Arezzo, Health Authorities South East Tuscany, Arezzo, Italy
- Azienda Sanitaria Friuli Occidentale, Pordenone, Italy
- Associazione Di Volontariato Piede Diabetico Umbria ODV, Perugia, Italy
| | - Benedetta Ragghianti
- Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy
- Azienda Sanitaria Friuli Occidentale, Pordenone, Italy
- Associazione Di Volontariato Piede Diabetico Umbria ODV, Perugia, Italy
| | - Cesare Miranda
- Pordenone Hospital, Pordenone, Italy
- Azienda Sanitaria Friuli Occidentale, Pordenone, Italy
- Associazione Di Volontariato Piede Diabetico Umbria ODV, Perugia, Italy
| | - Luca Monge
- AMD - Italian Association of Clinical Diabetologists, Rome, Italy
- Azienda Sanitaria Friuli Occidentale, Pordenone, Italy
- Associazione Di Volontariato Piede Diabetico Umbria ODV, Perugia, Italy
| | - Antonio Silverii
- Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy
- Azienda Sanitaria Friuli Occidentale, Pordenone, Italy
- Associazione Di Volontariato Piede Diabetico Umbria ODV, Perugia, Italy
| | - Luigi Uccioli
- Diabetes Section CTO Hospital and Dept of Biomedicine and Prevention Tor Vergata, University of Rome, Rome, Italy
- Azienda Sanitaria Friuli Occidentale, Pordenone, Italy
- Associazione Di Volontariato Piede Diabetico Umbria ODV, Perugia, Italy
| | - Cristiana Vermigli
- Azienda Sanitaria Friuli Occidentale, Pordenone, Italy
- Associazione Di Volontariato Piede Diabetico Umbria ODV, Perugia, Italy
- University Hospital Perugia, Perugia, Italy
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Gomez PT, Andrews KL, Arthurs JR, Bruce AJ, Wyles SP. Platelet-Rich Plasma in the Treatment of Diabetic Foot Ulcers. Adv Skin Wound Care 2024; 37:608-615. [PMID: 39792512 DOI: 10.1097/asw.0000000000000229] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/12/2025]
Abstract
BACKGROUND Chronic nonhealing neuropathic foot ulcers affect approximately 15% to 30% of patients with diabetes mellitus and are associated with significant morbidity and mortality. Although current strategies to address these chronic wounds include a multifactorial approach, clinical outcomes remain poor and warrant improvement. Platelet-rich plasma (PRP), derived from autologous or allogeneic blood, is an emerging regenerative product that aims to serve as an adjuvant to standard diabetic foot ulcer (DFU) treatment. OBJECTIVE To examine controlled clinical trials investigating the efficacy of platelet-rich therapies in promoting healing of chronic DFUs. DATA SOURCES The PubMed/MEDLINE database. STUDY SELECTION Researchers selected 11 controlled clinical trials published between 2011 and 2021 that investigated the efficacy of PRP treatments for chronic DFUs. DATA EXTRACTION Extracted data included study type and size, participant sex and age, duration of diabetes, glycated hemoglobin levels, baseline ulcer area, wound duration, healing parameters, PRP preparation approach, and application type. DATA SYNTHESIS Randomized prospective studies (n = 8), prospective controlled studies (n = 2), and a double-blind, randomized controlled study (n = 1) were included in the review. In general, PRP plus standard of care provided superior wound healing, in both percentage of wound closure and healing rate, compared with standard of care alone. CONCLUSIONS Use of PRP as an adjuvant for healing chronic DFUs appears to improve wound healing. Further research on optimizing PRP preparation and exploring combinatorial approaches will be important in advancing this avenue for chronic wound healing.
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Affiliation(s)
- Paul T Gomez
- At Mayo Clinic, Rochester, Minnesota, United States, Paul T. Gomez, BS, is Summer Research Fellow, Regenerative Sciences Track, Mayo Clinic Graduate School of Biomedical Sciences; Saranya P. Wyles, MD, PhD, is Consultant, Department of Dermatology; and Karen L. Andrews, MD, is Director, Vascular Ulcer and Wound Healing Clinic/Gonda Vascular Center, and Consultant, Department of Physical Medicine and Rehabilitation. At Mayo Clinic, Jacksonville, Florida, Jennifer R. Arthurs is APRN, Center for Regenerative Medicine; and Alison J. Bruce, MB, ChB, is Consultant, Department of Dermatology
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Ohura N, Kimura C, Ando H, Yuzuriha S, Furukawa M, Higashita R, Ayabe S, Tsuji Y, Fujii M, Terabe Y, Sakisaka M, Iwashina Y, Nakanishi A, Sasaki S, Hasegawa T, Kawauchi T, Hisamichi K. Efficacy of autologous platelet-rich plasma gel in patients with hard-to-heal diabetic foot ulcers: a multicentre study in Japan. J Wound Care 2024; 33:484-494. [PMID: 38967341 DOI: 10.12968/jowc.2023.0088] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/06/2024]
Abstract
OBJECTIVE To evaluate the healing outcome of a platelet-rich plasma (PRP) gel prepared using TKKT01 (a wound care device to prepare the PRP gel) in patients with hard-to-heal diabetic foot ulcers (DFUs) and who showed an inadequate response to ≥4 weeks of standard of care (SoC). METHOD This open-label, single-arm, multicentre study was conducted in 15 centres in Japan. Eligible patients received PRP gel treatment twice a week for eight weeks, followed by a final evaluation after the completion of week 8 (day 57). The primary endpoint was the percentage of patients who achieved ≥50% reduction in wound radius at the final evaluation (achievement criterion, ≥60% of patients). Secondary endpoints included: wound area and volume reduction rates; time to possible wound closure by secondary intention; time to possible wound closure using a relatively simple procedure (e.g., skin graft and suture); and safety at the final evaluation. RESULTS A total of 54 patients were included in the full analysis set, with 47 patients included in the per protocol set; the primary endpoint was met in 38/47 (80.9%) (95% confidence interval: 66.7-90.9%) patients who achieved ≥50% wound radius reduction at the final evaluation. High rates of wound area (72.8%) and volume (92.7%) reduction were observed at the final evaluation. The median time to possible wound closure by secondary intention and by use of a relatively simple procedure was 57 and 43 days, respectively. Complete wound closure at the final evaluation was achieved in 27 (57.4%) patients. No safety concerns were raised. CONCLUSION In this study, the efficacy and safety of PRP gel treatment with TKKT01 in patients with hard-to-heal DFUs in Japan were confirmed by our findings. DECLARATION OF INTEREST This study was funded by Rohto Pharmaceutical Co., Ltd., Japan. NO has been paid a consulting fee by Rohto Pharmaceutical Co., Ltd. KH is the Chief Medical Officer of Rohto Pharmaceutical. Co., Ltd. The other authors have no conflict of interest to declare.
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Affiliation(s)
- Norihiko Ohura
- Department of Plastic, Reconstructive Surgery, Kyorin University School of Medicine, Tokyo, Japan
| | - Chu Kimura
- Department of Plastic and Reconstructive Surgery, Hakodate General Central Hospital, Hakodate, Japan
| | - Hiroshi Ando
- Limb Salvage Center, Kasukabe Chuo General Hospital, Kasukabe, Japan
| | - Shunsuke Yuzuriha
- Department of Plastic and Reconstructive Surgery, Shinshu University School of Medicine, Matsumoto, Japan
| | | | - Ryuji Higashita
- Department of Cardiovascular Surgery, Yokohama General Hospital, Yokohama, Japan
| | - Shinobu Ayabe
- Department of Plastic Surgery, Yao Tokushukai General Hospital, Yao, Japan
| | - Yoriko Tsuji
- Department of Plastic Surgery, Shinsuma General Hospital, Kobe, Japan
| | - Miki Fujii
- Department of Plastic and Reconstructive Surgery, Kitaharima Medical Center, Ono, Japan
| | - Yuta Terabe
- Department of Plastic and Reconstructive Surgery, Tokyo Nishi Tokushukai Hospital, Akishima, Japan
| | - Masanobu Sakisaka
- Department of Plastic Surgery, Shizuoka Saiseikai General Hospital, Shizuoka, Japan
| | - Yuki Iwashina
- Department of Plastic, Reconstructive Surgery, Kyorin University School of Medicine, Tokyo, Japan
| | - Arata Nakanishi
- Department of Plastic and Reconstructive Surgery, Ikoma City Hospital, Ikoma, Japan
| | - Shigeru Sasaki
- Department of Vascular Surgery, Sendai Social Insurance Hospital, Sendai, Japan
| | - Toshio Hasegawa
- Department of Dermatology and Allergology, Juntendo University Shizuoka Hospital, Izunokuni, Japan
| | - Tsukasa Kawauchi
- Department of Plastic Surgery, Tomei Atsugi Hospital, Atsugi, Japan
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Wu Y, Peng G, Wang Y, Chen J, Zhang B, Tang J, Cheng B. Clinical efficacy of blood derivatives on wound healing: A systematic review and network meta-analysis. Int Wound J 2024; 21:e14622. [PMID: 38158884 PMCID: PMC10961890 DOI: 10.1111/iwj.14622] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/03/2023] [Accepted: 12/14/2023] [Indexed: 01/03/2024] Open
Abstract
This study aims to evaluate the clinical effects of different blood derivatives on wound healing using network meta-analysis. PubMed, Embase, OVID, Web of Science, SCOPUS and Cochrane Central were searched to obtain studies about blood derivatives on wound healing until October 2023. R 4.2.0 and Stata 15.0 softwares were used for data analysis. Forty-four studies comprising 5164 patients were included. The results of network meta-analysis showed that the healing area from high to low was GF + ORCCB, ORCCB, GF, PRF, Unnas paste dressing, APG, PRP injection, PRP, PRP + thrombin gel, PPP, HPL, CT. The healing time from low to high was PRP + thrombin gel, GF, PRP, PC + K, PC, APG, PRF, CT, Silver sulfadiazine ointment. The number of patients cured from high to low was APG, PRP injection, PRP, Aurix, PRF, Leucopatch, HPL, Antimicrobial Ointment Dressing, CT, 60 μg/cm2 repifermin, 120 μg/cm2 repifermin, AFG, PPP. The order of analgesic effect from high to low was AFG, Aminogam gel, PRF, PRP, Oxidised oil, APG, GF, CT. The order of the number of wound infection cases from low to high is APG, 20 μg/cm2 repifermin, 60 μg/cm2 repifermin, PRP, LeucoPatch, CT, PPP, Antiseptic ointment dressing. Healing area: GF + ORCCB had the best effect; Healing time: PRP + thrombin gel took the shortest time. The number of cured patients and the reduction of wound infection: APG has the best effect. Analgesic effect: AFG has the best effect. More studies with large sample sizes are needed to confirm the above findings.
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Affiliation(s)
- Yanhong Wu
- Department of Burns and Plastic SurgeryGeneral Hospital of Southern Theater Command of PLAGuangzhouGuangdongChina
| | - Guang Peng
- Department of Burns and Plastic SurgeryGeneral Hospital of Southern Theater Command of PLAGuangzhouGuangdongChina
| | - Yuzhi Wang
- Department of Burns and Plastic SurgeryGeneral Hospital of Southern Theater Command of PLAGuangzhouGuangdongChina
| | - Jianwu Chen
- Department of Burns and Plastic SurgeryGeneral Hospital of Southern Theater Command of PLAGuangzhouGuangdongChina
| | - Bin Zhang
- Department of Burns and Plastic SurgeryGeneral Hospital of Southern Theater Command of PLAGuangzhouGuangdongChina
| | - Jianbing Tang
- Department of Burns and Plastic SurgeryGeneral Hospital of Southern Theater Command of PLAGuangzhouGuangdongChina
| | - Biao Cheng
- Department of Burns and Plastic SurgeryGeneral Hospital of Southern Theater Command of PLAGuangzhouGuangdongChina
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Fang X, Wang X, Hou Y, Zhou L, Jiang Y, Wen X. Effect of platelet-rich plasma on healing of lower extremity diabetic skin ulcers: A meta-analysis. Int Wound J 2024; 21:e14856. [PMID: 38531532 PMCID: PMC10965316 DOI: 10.1111/iwj.14856] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/29/2024] [Accepted: 03/12/2024] [Indexed: 03/28/2024] Open
Abstract
The aim of this research is to explore the therapeutic efficacy of platelet-rich plasma (PRP) on the cutaneous ulceration of diabetes mellitus (DM). From the beginning of the database until January 2024, we looked through several databases to obtain randomised, controlled PRP studies to treat the wound healing of DM in adult patients. The Cochrane Collaboration's Risk-Of-Bias Instrument was used to evaluate the risk of bias in randomised, controlled studies. Funnel plots, sensitivity analyses and Egger regression tests were employed to determine the reliability and effectiveness of the meta-analyses. Depending on the degree of heterogeneity, a fixed or random effect model has been used. The statistical significance was determined to be below 0.05. Altogether 281 trials were collected from the database and entered into Endnote Software for screening, and 15 trials were analysed. It was found that PRP was associated with a higher rate of wound healing (OR, 3.23; 95% CI, 2.42, 4.31 p < 0.0001). PRP was associated with a reduction in the risk of post-operative wound infection (OR, 0.46; 95% CI, 0.21, 0.99 p = 0.05). PRP was associated with a reduction in the risk of amputations amongst those with DM (OR, 0.50; 95% CI, 0.30, 0.84 p = 0.009). Overall, PRP treatment for DM is expected to improve the rate of wound healing, decrease the risk of wound infection and decrease the risk of amputations.
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Affiliation(s)
- Xiansong Fang
- Department of Blood transfusionFirst Affiliated Hospital of Gannan Medical UniversityGanzhouChina
| | - Xiaoling Wang
- Department of Clinical LaboratoryFirst Affiliated Hospital of Gannan Medical UniversityGanzhouChina
| | - Ya Hou
- The First School of Clinical Medicine, Gannan Medical UniversityGanzhouChina
| | - Liang Zhou
- The First School of Clinical Medicine, Gannan Medical UniversityGanzhouChina
| | - Yingjie Jiang
- The First School of Clinical Medicine, Gannan Medical UniversityGanzhouChina
| | - Xiaoyun Wen
- Department of Clinical LaboratoryFirst Affiliated Hospital of Gannan Medical UniversityGanzhouChina
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Chen P, Vilorio NC, Dhatariya K, Jeffcoate W, Lobmann R, McIntosh C, Piaggesi A, Steinberg J, Vas P, Viswanathan V, Wu S, Game F. Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review. Diabetes Metab Res Rev 2024; 40:e3786. [PMID: 38507616 DOI: 10.1002/dmrr.3786] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2024] [Accepted: 02/27/2024] [Indexed: 03/22/2024]
Abstract
BACKGROUND It is critical that interventions used to enhance the healing of chronic foot ulcers in diabetes are backed by high-quality evidence and cost-effectiveness. In previous years, the systematic review accompanying guidelines published by the International Working Group of the Diabetic Foot performed 4-yearly updates of previous searches, including trials of prospective, cross-sectional and case-control design. AIMS Due to a need to re-evaluate older studies against newer standards of reporting and assessment of risk of bias, we performed a whole new search from conception, but limiting studies to randomised control trials only. MATERIALS AND METHODS For this systematic review, we searched PubMed, Scopus and Web of Science databases for published studies on randomised control trials of interventions to enhance healing of diabetes-related foot ulcers. We only included trials comparing interventions to standard of care. Two independent reviewers selected articles for inclusion and assessed relevant outcomes as well as methodological quality. RESULTS The literature search identified 22,250 articles, of which 262 were selected for full text review across 10 categories of interventions. Overall, the certainty of evidence for a majority of wound healing interventions was low or very low, with moderate evidence existing for two interventions (sucrose-octasulfate and leucocyte, platelet and fibrin patch) and low quality evidence for a further four (hyperbaric oxygen, topical oxygen, placental derived products and negative pressure wound therapy). The majority of interventions had insufficient evidence. CONCLUSION Overall, the evidence to support any other intervention to enhance wound healing is lacking and further high-quality randomised control trials are encouraged.
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Affiliation(s)
- Pam Chen
- Joondalup Health Campus, Ramsay Healthcare Australia, Joondalup, Western Australia, Australia
- Faculty of Health, University of Tasmania, Hobart, Tasmania, Australia
| | - Nalini Campillo Vilorio
- Department of Diabetology, Diabetic Foot Unit, Plaza de la Salud General Hospital, Santo Domingo, Dominican Republic
| | - Ketan Dhatariya
- Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK
- Norwich Medical School, University of East Anglia, Norwich, UK
| | | | - Ralf Lobmann
- Clinic for Endocrinology, Diabetology and Geriatrics, Klinikum Stuttgart, Stuttgart, Germany
| | | | - Alberto Piaggesi
- Diabetic Foot Section, Department of Medicine, University of Pisa, Pisa, Italy
| | - John Steinberg
- Georgetown University School of Medicine, Washington, District of Columbia, USA
| | - Prash Vas
- King's College Hospital NHS Foundation Trust, London, UK
| | - Vijay Viswanathan
- MV Hospital for Diabetes and Prof M Viswanathan Diabetes Research Center, Chennai, India
| | - Stephanie Wu
- Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, USA
| | - Fran Game
- University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
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Chen P, Vilorio NC, Dhatariya K, Jeffcoate W, Lobmann R, McIntosh C, Piaggesi A, Steinberg J, Vas P, Viswanathan V, Wu S, Game F. Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update). Diabetes Metab Res Rev 2024; 40:e3644. [PMID: 37232034 DOI: 10.1002/dmrr.3644] [Citation(s) in RCA: 69] [Impact Index Per Article: 69.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/15/2023] [Accepted: 04/17/2023] [Indexed: 05/27/2023]
Abstract
AIMS Principles of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are of utmost importance when attempting to heal a chronic diabetes-related foot ulcer. However, the rising incidence and costs of diabetes-related foot ulcer management necessitate that interventions to enhance wound healing of chronic diabetes-related foot ulcers are supported by high-quality evidence of efficacy and cost effectiveness when used in conjunction with established aspects of gold-standard multidisciplinary care. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence-based guideline on wound healing interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline. MATERIALS AND METHODS We followed the GRADE approach by devising clinical questions and important outcomes in the Patient-Intervention-Control-Outcome (PICO) format, undertaking a systematic review, developing summary of judgements tables, and writing recommendations and rationale for each question. Each recommendation is based on the evidence found in the systematic review and, using the GRADE summary of judgement items, including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability, we formulated recommendations that were agreed by the authors and reviewed by independent experts and stakeholders. RESULTS From the results of the systematic review and evidence-to-decision making process, we were able to make 29 separate recommendations. We made a number of conditional supportive recommendations for the use of interventions to improve healing of foot ulcers in people with diabetes. These include the use of sucrose octasulfate dressings, the use of negative pressure wound therapies for post-operative wounds, the use of placental-derived products, the use of the autologous leucocyte/platelet/fibrin patch, the use of topical oxygen therapy, and the use of hyperbaric oxygen. Although in all cases it was stressed that these should be used where best standard of care was not able to heal the wound alone and where resources were available for the interventions. CONCLUSIONS These wound healing recommendations should support improved outcomes for people with diabetes and ulcers of the foot, and we hope that widescale implementation will follow. However, although the certainty of much of the evidence on which to base the recommendations is improving, it remains poor overall. We encourage not more, but better quality trials including those with a health economic analysis, into this area.
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Affiliation(s)
- Pam Chen
- Joondalup Health Campus, Ramsay Healthcare Australia, Joondalup, Western Australia, Australia
- Faculty of Health, University of Tasmania, Hobart, Tasmania, Australia
| | - Nalini Campillo Vilorio
- Department of Diabetology, Diabetic Foot Unit, Plaza de la Salud General Hospital, Santo Domingo, Dominican Republic
| | - Ketan Dhatariya
- Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK
- Norwich Medical School, University of East Anglia, Norwich, UK
| | | | - Ralf Lobmann
- Clinic for Endocrinology, Diabetology and Geriatrics, Klinikum Stuttgart, Stuttgart, Germany
| | - Caroline McIntosh
- Podiatric Medicine, School of Health Sciences, University of Galway, Galway, Ireland
| | - Alberto Piaggesi
- Diabetic Foot Section, Department of Medicine, University of Pisa, Pisa, Italy
| | - John Steinberg
- Georgetown University School of Medicine, Georgetown, Washington DC, USA
| | - Prash Vas
- King's College Hospital NHS Foundation Trust, London, UK
| | - Vijay Viswanathan
- MV Hospital for Diabetes and Prof M Viswanathan Diabetes Research Center, Chennai, India
| | - Stephanie Wu
- Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, USA
| | - Fran Game
- University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
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11
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Du YL, Lim P, Isseroff R, Dahle S. Patterns of use of advanced wound matrices in the Veterans Administration clinics. Wound Repair Regen 2024; 32:118-122. [PMID: 38217307 DOI: 10.1111/wrr.13150] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/09/2023] [Revised: 11/14/2023] [Accepted: 12/10/2023] [Indexed: 01/15/2024]
Abstract
Chronic wounds are a common and costly health issue affecting millions of individuals in the United States, particularly those with underlying conditions such as diabetes, venous insufficiency, and peripheral artery disease. When standard treatments fail, advanced wound care therapies, such as skin substitutes, are often applied. However, the clinical effectiveness, indications, and comparative benefits of these therapies have not been well established. In this study, we report on the usage of both acellular and cellular, single and bilayer, natural and synthetic, dermal, and epidermal skin substitutes in a VA hospital system. We performed a retrospective chart review to understand the ordering and usage patterns of advanced wound therapies for patients with chronic wounds at the VA Northern California Health Care System. We examined types of products being recommended, categories of users recommending the products, indications for orders, and rate of repeated orders. Neuropathic, venous, or pressure ulcers were the main indications for using advanced wound matrices. Only 15.6% of patients for whom the matrices were ordered had supporting laboratory tests. Exactly 34.3% of the ordered matrices were not applied. And the use of wound matrices resulted in increased costs per patient visit of $1018-$3450. Our study sheds light on the usage patterns of these therapies in a VA healthcare facility and highlights the need for more robust evidence-based studies to determine the true benefits, efficacy, and cost-effectiveness of these innovative treatment options.
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Affiliation(s)
- Yimeng Lina Du
- University of California Davis, School of Medicine, Sacramento, California, USA
| | - Pallas Lim
- Dermatology Section, VA Northern California Health Care System, Mather, California, USA
| | - Rivkah Isseroff
- Dermatology Section, VA Northern California Health Care System, Mather, California, USA
- Department of Dermatology, University of California Davis, Sacramento, California, USA
| | - Sara Dahle
- Department of Dermatology, University of California Davis, Sacramento, California, USA
- Podiatry Section, VA Northern California Health Care System, Mather, California, USA
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12
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Ruiz-Muñoz M, Martinez-Barrios FJ, Fernandez-Torres R, Lopezosa-Reca E, Marchena-Rodriguez A. Autologous platelet-rich plasma (APRP) in diabetes foot disease: a meta-analysis. J Diabetes Complications 2024; 38:108690. [PMID: 38278034 DOI: 10.1016/j.jdiacomp.2024.108690] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2023] [Revised: 01/08/2024] [Accepted: 01/11/2024] [Indexed: 01/28/2024]
Abstract
INTRODUCTION This study will explore the effectiveness of autologous platelet-rich plasma in the treatment of diabetic foot disease compared to conventional treatments, based on the ulcer healing rate. METHODS The electronic databases of PubMed, EMBASE, and WOS internet were searched. Evaluated outcome rate of complete ulcer healing. Statistical analysis was performed with RevMan 5.0 software and SPSS 25.0. RESULTS Eleven RCTs with 828 patients were included in this study. The meta-analysis showed a higher complete ulcer healing rate (OR = 3.69, 95 % CI 2.62 to 5.20, P < 0.01, I2 = 0 %) in growth factors based in autologous platelech-rich plasma (aPRP) group compared with control. Mixed evidence was seen for publication bias, but analyses by using the trim-and-fill method did not appreciably alter results. CONCLUSION Autologous platelet-rich plasma can improve the complete healing rate of the ulcer compared to current conventional treatments in diabetic foot ulcer patients.
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Affiliation(s)
- Maria Ruiz-Muñoz
- Department Nursing and Podiatry, Faculty of Health Sciences, University of Málaga, Málaga, Spain.
| | | | - Raul Fernandez-Torres
- Department Nursing and Podiatry, Faculty of Health Sciences, University of Málaga, Málaga, Spain.
| | - Eva Lopezosa-Reca
- Department Nursing and Podiatry, Faculty of Health Sciences, University of Málaga, Málaga, Spain.
| | - Ana Marchena-Rodriguez
- Department Nursing and Podiatry, Faculty of Health Sciences, University of Málaga, Málaga, Spain.
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13
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Platini H, Adammayanti KA, Maulana S, Putri PMK, Layuk WG, Lele JAJMN, Haroen H, Pratiwi SH, Musthofa F, Mago A. The Potential of Autologous Platelet-Rich Plasma Gel for Diabetic Foot Ulcer Care Among Older Adults: A Systematic Review and Meta-Analysis. Ther Clin Risk Manag 2024; 20:21-37. [PMID: 38288358 PMCID: PMC10823873 DOI: 10.2147/tcrm.s433033] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2023] [Accepted: 01/22/2024] [Indexed: 01/31/2024] Open
Abstract
Introduction Poorly controlled diabetes mellitus can lead to the development of diabetic foot ulcers (DFU), which is a frequent complication in patients. However, several diabetes management guidelines for older adults do not mention the occurrence of DFUs. Nowadays, Autologous Platelet-Rich Gel (APG) is being used for treating diabetic ulcers. APG is an innovative platelet-derived product with many advantages, such as being low-cost, easy to produce, and readily available materials. Additionally, it does not lead to any rejection reaction. Objective This study aims to assess the safety and efficacy of APG as a novel treatment of DFU compared with standard treatment in older adult patients. Methods Randomized Controlled Trials (RCTs) were searched using PubMed, Cochrane, Google Scholar, Wiley, and PlosOne. The keywords have been arranged using the Boolean operator, including autologous platelet-rich gel, DFU, and elderly. The data was screened by inclusion and exclusion criteria. The final inclusion study was analyzed and synthesized by tabulation, clusterization, contextual and thematic approach, and assessed for risk of bias using ROB 2.0. Meta-analysis was conducted by using Review Manager 5.4 and the Mantel Haenszel method. Results Eight RCTs with 598 patients were eligible for the present analysis. Compared with standard care/conventional treatment, APG could significantly improve the healing wound in patients with diabetic foot ulcers (Relative risk (RR) 1.32, 95% confidence interval (CI) 1.22-1.57, p < 0.0001), shortened the healing time (Mean difference [MD] -16.97 days (95% CI: -32.64 to -1.29; p < 0.00001), shortened the length of hospital stay (MD= -20.11, 95% CI: -38.02, -2.20; p = 0.03), and amputation rate (MD= 0.36, 95% CI: 0.16, 0.84; p = 0.02). Conclusion APG treatment can better treat DFU in terms of duration of healing, wound healing, length of hospital stay, and amputation prevention than the standard treatment.
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Affiliation(s)
- Hesti Platini
- Department of Medical-Surgical Nursing, Faculty of Nursing, Universitas Padjadjaran, Sumedang, West Java, Indonesia
| | - Keyzha Amartya Adammayanti
- Clinical Clerkship Program, Faculty of Medicine, Universitas Kristen Indonesia (UKI), UKI Hospital East Jakarta, Special Capital Region, Indonesia
| | - Sidik Maulana
- Master of Nursing Program, Faculty of Nursing, Universitas Padjadjaran, Sumedang, West Java, Indonesia
| | - Putu Moradha Kharisma Putri
- Clinical Clerkship Program, Faculty of Medicine, Universitas Kristen Indonesia (UKI), UKI Hospital East Jakarta, Special Capital Region, Indonesia
| | - Welly Grivin Layuk
- Clinical Clerkship Program, Faculty of Medicine, Universitas Kristen Indonesia (UKI), UKI Hospital East Jakarta, Special Capital Region, Indonesia
| | | | - Hartiah Haroen
- Department of Community Health Nursing, Faculty of Nursing, Universitas Padjadjaran, Sumedang, West Java, Indonesia
| | - Sri Hartati Pratiwi
- Department of Medical-Surgical Nursing, Faculty of Nursing, Universitas Padjadjaran, Sumedang, West Java, Indonesia
| | - Faizal Musthofa
- Nursing Internship Program, Faculty of Nursing, Universitas Padjadjaran, Sumedang, West Java, Indonesia
- West Sapphire Medical-Surgical Ward, Santosa Bandung Central, Bandung, West Java, Indonesia
| | - Arpit Mago
- Department of Clinical Medicine, Jawaharlal Nehru Medical College, Belagavi, India
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Su YN, Li J, Feng DH, Lu RR, Dong GX, Zhao DY. Efficacy and safety of autologous platelet-rich plasma for diabetic foot ulcers: a systematic review and meta-analysis. J Wound Care 2023; 32:773-786. [PMID: 38060413 DOI: 10.12968/jowc.2023.32.12.773] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2023]
Abstract
OBJECTIVE To investigate the efficacy and safety of autologous platelet-rich plasma (au-PRP) for diabetic foot ulcer (DFU) treatment. METHOD We conducted database searches (MEDLINE, EMBASE, evidence-based medicine reviews: CENTRAL, PubMed, and Web of Science) and reference mining for randomised controlled trials from inception to 23 January 2022. Results were scrutinised, data were extracted and research quality was investigated by two independent authors. Primary outcome was the proportion of complete ulcer healing. Secondary outcomes included both the mean time to complete healing and the incidence of adverse events. Statistical analyses were performed in RevMan 5.4 (Cochrane, UK). Kaplan-Meier curves for time to complete healing were pooled in R software (version 4.1.2) (R Foundation, Austria). RESULTS Of the 231 records identified, 17 studies with a total of 1303 participants (649 randomised to the au-PRP group and 654 to a standard of care (SOC) group) met the eligibility criteria and were included in our study. Compared with SOC, au-PRP appeared to promote the complete healing rate (odds ratio (OR): 2.11; 95% Confidence Interval: 1.55-2.86). Au-PRP also appeared to significantly shorten complete healing time (mean duration: -19.04 days; 95%CI: -20.46--17.61]). There was no significant difference on adverse events. Results were robust on sensitivity analyses. CONCLUSION Based on the findings of this review and meta-analysis, Au-PRP is an effective and safe adjuvant therapy for DFUs.
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Affiliation(s)
- Ya-Na Su
- Department of Health Management, The School of Smart Health and Wellness (Health Medical College), Zhejiang Dongfang Polytechnic, Wenzhou City, Zhejiang Province, PR China
| | - Jing Li
- Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Chengdu City, Sichuan Province, PR China
- The Chinese Cochrane Center, Chengdu City, Sichuan Province, PR China
| | - Dai-Hao Feng
- Department of Elderly Services and Management, The School of Smart Health and Wellness (Health Medical College), Zhejiang Dongfang Polytechnic, Wenzhou City, Zhejiang Province, PR China
| | - Ruo-Ruo Lu
- Department of Elderly Services and Management, The School of Smart Health and Wellness (Health Medical College), Zhejiang Dongfang Polytechnic, Wenzhou City, Zhejiang Province, PR China
| | - Guo-Xi Dong
- Department of Nursing Teaching and Research, The School of Smart Health and Wellness (Health Medical College), Zhejiang Dongfang Polytechnic, Wenzhou City, Zhejiang Province, PR China
| | - Ding-Yun Zhao
- Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou City, Zhejiang Province, PR China
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15
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Thanigaimani S, Jin H, Ahmad U, Anbalagan R, Golledge J. Comparative efficacy of growth factor therapy in healing diabetes-related foot ulcers: A network meta-analysis of randomized controlled trials. Diabetes Metab Res Rev 2023; 39:e3670. [PMID: 37277960 PMCID: PMC10909411 DOI: 10.1002/dmrr.3670] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/13/2022] [Revised: 03/01/2023] [Accepted: 04/26/2023] [Indexed: 06/07/2023]
Abstract
INTRODUCTION This study examined the relative efficacy of growth factor therapies in healing diabetes-related foot ulcers (DFU). METHODS PubMed and Cochrane databases were searched for randomized controlled trials testing growth factor therapies for treating DFU. The primary outcome was complete wound closure. Results were reported as relative risk (RR) ± 95% credible intervals (CrI). The risk of bias was assessed using Cochrane's RoB-2 tool. RESULTS A total of 31 RCTs involving 2174 participants were included. Only 13 of the trials (n = 924) reported on the aetiology of the ulcers (85.4% neuropathic and 14.6% ischaemic). Epidermal growth factor (RR 3.83; 95% CrI 1.81, 9.10), plasma-rich protein (PRP) (RR 3.36; 95% CrI 1.66, 8.03) and platelet-derived growth factor (PDGF) (RR 2.47; 95% CrI 1.23, 5.17) significantly improved the likelihood of complete ulcer healing compared to control. Sub-analyses suggested that PRP (3 trials - RR 9.69; 95% CrI 1.37, 103.37) and PDGF (6 trials - RR 2.22; 95% CrI 1.12, 5.19) significantly improved the likelihood of wound closure amongst trial mainly recruiting participants with neuropathic ulcers. Eleven trials had a low risk of bias, 9 had some concerns and 11 had a high risk of bias. Sub-analysis of trials with a low risk of bias suggested that none of the growth factors significantly improved ulcer healing compared with control. DISCUSSION This network meta-analysis found low-quality evidence that Epidermal growth factor, PRP and PDGF therapy improved DFU healing likelihood compared with control. Larger well-designed trials are needed.
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Affiliation(s)
- Shivshankar Thanigaimani
- Queensland Research Centre for Peripheral Vascular DiseaseCollege of Medicine and DentistryJames Cook UniversityTownsvilleQueenslandAustralia
- The Australian Institute of Tropical Health and MedicineJames Cook UniversityTownsvilleQueenslandAustralia
| | - Harry Jin
- Queensland Research Centre for Peripheral Vascular DiseaseCollege of Medicine and DentistryJames Cook UniversityTownsvilleQueenslandAustralia
| | - Usama Ahmad
- Queensland Research Centre for Peripheral Vascular DiseaseCollege of Medicine and DentistryJames Cook UniversityTownsvilleQueenslandAustralia
| | - Raghuveeran Anbalagan
- Queensland Research Centre for Peripheral Vascular DiseaseCollege of Medicine and DentistryJames Cook UniversityTownsvilleQueenslandAustralia
- The Australian Institute of Tropical Health and MedicineJames Cook UniversityTownsvilleQueenslandAustralia
| | - Jonathan Golledge
- Queensland Research Centre for Peripheral Vascular DiseaseCollege of Medicine and DentistryJames Cook UniversityTownsvilleQueenslandAustralia
- The Australian Institute of Tropical Health and MedicineJames Cook UniversityTownsvilleQueenslandAustralia
- The Department of Vascular and Endovascular SurgeryTownsville University HospitalTownsvilleQueenslandAustralia
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Meznerics FA, Fehérvári P, Dembrovszky F, Kovács KD, Kemény LV, Csupor D, Hegyi P, Bánvölgyi A. Platelet-Rich Plasma in Chronic Wound Management: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. J Clin Med 2022; 11:7532. [PMID: 36556151 PMCID: PMC9785167 DOI: 10.3390/jcm11247532] [Citation(s) in RCA: 22] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2022] [Revised: 12/08/2022] [Accepted: 12/14/2022] [Indexed: 12/23/2022] Open
Abstract
BACKGROUND Chronic wounds place a heavy burden on the healthcare system due to the prolonged, continuous need for human resources for wound management. Our aim was to investigate the therapeutic effects of platelet-rich plasma on the treatment of chronic wounds. METHODS The systematic literature search was performed in four databases. Randomized clinical trials reporting on patients with chronic wounds treated with platelet-rich plasma (PRP) were included, comparing PRP with conventional ulcer therapy. We pooled the data using the random effects model. Our primary outcome was the change in wound size. RESULTS Our systematic search provided 2688 articles, and we identified 48 eligible studies after the selection and citation search. Thirty-three study groups of 29 RCTs with a total of 2198 wounds showed that the odds for complete closure were significantly higher in the PRP group than in the control group (OR = 5.32; CI: 3.37; 8.40; I2 = 58%). CONCLUSIONS PRP is a safe and effective modality to enhance wound healing. By implementing it in clinical practice, platelet-rich plasma could become a widely used, valuable tool as it could not only improve patients' quality of life but also decrease the healthcare burden of wound management.
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Affiliation(s)
- Fanni Adél Meznerics
- Department of Dermatology, Venereology and Dermatooncology, Faculty of Medicine, Semmelweis University, 1085 Budapest, Hungary
- Centre for Translational Medicine, Semmelweis University, 1085 Budapest, Hungary
| | - Péter Fehérvári
- Centre for Translational Medicine, Semmelweis University, 1085 Budapest, Hungary
- Department of Biostatistics, University of Veterinary Medicine, 1085 Budapest, Hungary
| | - Fanni Dembrovszky
- Centre for Translational Medicine, Semmelweis University, 1085 Budapest, Hungary
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, 7624 Pécs, Hungary
| | - Kata Dorottya Kovács
- Department of Dermatology, Venereology and Dermatooncology, Faculty of Medicine, Semmelweis University, 1085 Budapest, Hungary
| | - Lajos Vince Kemény
- Department of Dermatology, Venereology and Dermatooncology, Faculty of Medicine, Semmelweis University, 1085 Budapest, Hungary
- HCEMM-SU Translational Dermatology Research Group, Department of Physiology, Semmelweis University, 1094 Budapest, Hungary
| | - Dezső Csupor
- Centre for Translational Medicine, Semmelweis University, 1085 Budapest, Hungary
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, 7624 Pécs, Hungary
- Institute of Clinical Pharmacy, Faculty of Pharmacy, University of Szeged, 6720 Szeged, Hungary
| | - Péter Hegyi
- Centre for Translational Medicine, Semmelweis University, 1085 Budapest, Hungary
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, 7624 Pécs, Hungary
- Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, 1085 Budapest, Hungary
| | - András Bánvölgyi
- Department of Dermatology, Venereology and Dermatooncology, Faculty of Medicine, Semmelweis University, 1085 Budapest, Hungary
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Beheshtizadeh N, Gharibshahian M, Pazhouhnia Z, Rostami M, Zangi AR, Maleki R, Azar HK, Zalouli V, Rajavand H, Farzin A, Lotfibakhshaiesh N, Sefat F, Azami M, Webster TJ, Rezaei N. Commercialization and regulation of regenerative medicine products: Promises, advances and challenges. Biomed Pharmacother 2022; 153:113431. [DOI: 10.1016/j.biopha.2022.113431] [Citation(s) in RCA: 26] [Impact Index Per Article: 8.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2022] [Revised: 07/04/2022] [Accepted: 07/14/2022] [Indexed: 11/02/2022] Open
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A Net Meta-Analysis of the Effectiveness of Different Types of Dressings in the Treatment of Diabetic Foot. COMPUTATIONAL AND MATHEMATICAL METHODS IN MEDICINE 2022; 2022:4915402. [PMID: 35898487 PMCID: PMC9313931 DOI: 10.1155/2022/4915402] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/17/2022] [Revised: 06/14/2022] [Accepted: 06/16/2022] [Indexed: 11/28/2022]
Abstract
Objective This is an analysis of the impact of a new dressing commonly used to treat diabetic foot (DFU). Methods Chinese and English databases were searched to collect clinical randomized controlled studies (RCTs) of various types of dressings for the treatment of DFU, and the healing rates of the different dressings were combined by reticulation meta-analysis. Results The aggregate of the 36 RCTs included in this study analysed the healing rates of nine dressings: conventional dressing, alginate dressing, chitosan dressing, hyaluronic acid dressing, platelet-rich plasma dressing, amniotic membrane dressing, honey dressing, human recombinant growth factor dressing, and silver ionomer dressing. Conclusion Hyaluronic acid dressing, amniotic membrane dressing, honey dressing, and platelet-rich plasma dressing are the ideal materials for topical treatment of DFU.
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Qu W, Wang Z, Hunt C, Morrow AS, Urtecho M, Amin M, Shah S, Hasan B, Abd-Rabu R, Ashmore Z, Kubrova E, Prokop LJ, Murad MH. The Effectiveness and Safety of Platelet-Rich Plasma for Chronic Wounds: A Systematic Review and Meta-analysis. Mayo Clin Proc 2021; 96:2407-2417. [PMID: 34226023 DOI: 10.1016/j.mayocp.2021.01.030] [Citation(s) in RCA: 33] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/19/2020] [Revised: 01/16/2021] [Accepted: 01/26/2021] [Indexed: 01/02/2023]
Abstract
OBJECTIVE To evaluate the effectiveness and adverse events of autologous platelet-rich plasma (PRP) in individuals with lower-extremity diabetic ulcers, lower-extremity venous ulcers, and pressure ulcers. PATIENTS AND METHODS We searched multiple databases from database inception to June 11, 2020, for randomized controlled trials and observational studies that compared PRP to any other wound care without PRP in adults with lower-extremity diabetic ulcers, lower-extremity venous ulcers, and pressure ulcers. RESULTS We included 20 randomized controlled trials and five observational studies. Compared with management without PRP, PRP therapy significantly increased complete wound closure in lower-extremity diabetic ulcers (relative risk, 1.20; 95% CI, 1.09 to 1.32, moderate strength of evidence [SOE]), shortened time to complete wound closure, and reduced wound area and depth (low SOE). No significant changes were found in terms of wound infection, amputation, wound recurrence, or hospitalization. In patients with lower-extremity venous ulcers or pressure ulcers, the SOE was insufficient to estimate an effect on critical outcomes, such as complete wound closure or time to complete wound closure. There was no statistically significant difference in adverse events. CONCLUSION Autologous PRP may increase complete wound closure, shorten healing time, and reduce wound size in individuals with lower-extremity diabetic ulcers. The evidence is insufficient to estimate an effect on wound healing in individuals with lower-extremity venous ulcers or pressure ulcers. TRIAL REGISTRATION PROSPERO Identifier: CRD42020172817.
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Affiliation(s)
- Wenchun Qu
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Department of Pain Medicine, Mayo Clinic, Jacksonville, FL
| | - Zhen Wang
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN; Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN.
| | - Christine Hunt
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Division of Pain Medicine, Department of Anaesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN
| | - Allison S Morrow
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Meritxell Urtecho
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Mustapha Amin
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Sahrish Shah
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Bashar Hasan
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Rami Abd-Rabu
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Zack Ashmore
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Division of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN
| | - Eva Kubrova
- Department of Pain Medicine, Mayo Clinic, Jacksonville, FL
| | - Larry J Prokop
- Department of Library-Public Services, Mayo Clinic, Rochester, MN
| | - Mohammad Hassan Murad
- Mayo Clinic Evidence-based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
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Fu XJ, Hu SD, Peng YF, Zhou LY, Shu T, Song DD. Observation of the effect of one-to-one education on high-risk cases of diabetic foot. World J Clin Cases 2021; 9:3265-3272. [PMID: 34002135 PMCID: PMC8107901 DOI: 10.12998/wjcc.v9.i14.3265] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/15/2020] [Revised: 01/20/2021] [Accepted: 03/13/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Diabetes is a common chronic disease, and its global incidence is on the rise. The disease is directly attributed to insufficient insulin efficacy/secretion, and patients are often accompanied by multiple complications. Diabetic foot is one of the most common complications of diabetes. Diabetic feet have ulcers and infections, which can eventually lead to amputation. Basic nursing care, such as lowering blood pressure and preventing foot skin infections in clinical nursing work, has positive significance for the prevention and control of diabetic feet.
AIM To explore the positive significance of one-to-one education in high-risk cases of diabetic foot.
METHODS This observation included 98 high-risk cases of diabetic foot in our hospital during the period from August 2017 to October 2019, and these patients were randomly divided into the basic nursing group and the one-to-one education group with 49 patients per group. The basic nursing group only received routine basic nursing, while the one-to-one education group gave patients one-to-one education on the basis of basic nursing. After nursing, the self-care ability and compliance behavior of the two groups were evaluated and compared between these two groups. The knowledge mastery of the patient and the satisfaction of nursing were accounted.
RESULTS The assessment results of patients (self-care responsibility, self-care skills, self-concept and self-care knowledge) were significantly higher in the one-to-one education group than in the basic nursing group. The scores of compliance behaviors (foot bathing, shoes and socks selection, sports health care) in the one-to-one education group were significantly higher than those in the basic nursing group. Patients in the one-to-one education group had a significantly higher level of knowledge mastery and satisfaction of nursing than the basic nursing group.
CONCLUSION One-to-one education for high-risk cases of diabetic foot is helpful to improve the cognition and self-care ability of patients with diabetic foot, to ensure that patients follow the doctor’s advice of self-care and to improve their nursing satisfaction.
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Affiliation(s)
- Xia-Jun Fu
- Department of Endocrinology and Metabolism, The Third Affiliated Hospital, Southern Medical University, Guangzhou 510630, Guangdong Province, China
| | - Shi-Di Hu
- Department of Endocrinology and Metabolism, The Third Affiliated Hospital, Southern Medical University, Guangzhou 510630, Guangdong Province, China
| | - Yin-Fang Peng
- Department of Endocrinology and Metabolism, The Third Affiliated Hospital, Southern Medical University, Guangzhou 510630, Guangdong Province, China
| | - Ling-Yan Zhou
- Department of Endocrinology and Metabolism, The Third Affiliated Hospital, Southern Medical University, Guangzhou 510630, Guangdong Province, China
| | - Ting Shu
- Department of Endocrinology and Metabolism, The Third Affiliated Hospital, Southern Medical University, Guangzhou 510630, Guangdong Province, China
| | - Dan-Dan Song
- Department of Endocrinology and Metabolism, The Third Affiliated Hospital, Southern Medical University, Guangzhou 510630, Guangdong Province, China
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de Sousa GP, Fontenele MKA, da Rocha RB, Cardoso VS. Update of Topical Interventions for Healing Diabetic Ulcers-A Systematic Review. INT J LOW EXTR WOUND 2021; 22:222-234. [PMID: 33949242 DOI: 10.1177/15347346211013189] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]
Abstract
There are a variety of dressings for wound healing. For this reason, research can assist in the choice and proper use of the intervention. This current view of the effectiveness of dressing on diabetic foot ulcers (DFUs) in patients with type 2 diabetes mellitus. This study is a systematic review of clinical trials selected in 4 databases: PubMed, Scopus, Web of Science, and Cochrane. Studies without language restriction, published between 2009 and 2020, were included. The search resulted in the identification of 5651 articles, of which 58 met all inclusion criteria. Among these, 2 biomaterials (D-acellular dermal matrix and keratinocyte) and phenytoin were highlighted for achieving healing rates of 100% and 95.82% ± 2.22%, respectively. The literature presents several alternatives with different actions, cure rates, reduction rates, and varied cost benefits. The growth in the use of biomaterials for the treatment of DFU can be seen in this study.
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Affiliation(s)
- Geice P de Sousa
- Center of Medical Specialties, Parnaíba, Piauí, Brazil.,School of Physical Therapy, 67823Federal University of Piauí, Parnaíba, Piauí, Brazil
| | - Maria K A Fontenele
- Center of Medical Specialties, Parnaíba, Piauí, Brazil.,School of Physical Therapy, 67823Federal University of Piauí, Parnaíba, Piauí, Brazil
| | - Rebeca B da Rocha
- Center of Medical Specialties, Parnaíba, Piauí, Brazil.,Postgraduate Program in Biomedical Sciences, 67823Federal University of Piauí, Parnaíba, Piauí, Brazil
| | - Vinicius S Cardoso
- Center of Medical Specialties, Parnaíba, Piauí, Brazil.,School of Physical Therapy, 67823Federal University of Piauí, Parnaíba, Piauí, Brazil.,Postgraduate Program in Biomedical Sciences, 67823Federal University of Piauí, Parnaíba, Piauí, Brazil
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