Efficacy of Huangma Ding or autologous platelet-rich gel for the diabetic lower extremity arterial disease patients with foot ulcers

doi:10.4239/wjd.v15.i5.923

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World Journal of Diabetes

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1948-9358

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Clinical Trials Study

World J Diabetes. May 15, 2024; 15(5): 923-934
Published online May 15, 2024. doi: 10.4239/wjd.v15.i5.923

Table 1 Baseline characteristics of patients in each group (mean ± SD)

Parameter	Group A	Group B	Group C	P value
n	62	38	55
Age (yr)	60.83 ± 11.28	63.26 ± 10.94	62.89 ± 7.71	0. 401
Duration (yr)	9.81 ± 8.66	9.34 ± 6.68	7.31 ± 5.28	0.148
Weight (kg)	61.28 ± 7.47	60.60 ± 10.90	58.33 ± 8.52	0.178
Height (m)	1.63 ± 0.07	1.60 ± 0.10	1.61 ± 0.06	0.255
FPG (mmol/L)	8.45 ± 2.21	7.38 ± 3.18	8.40 ± 4.25	0.239
White blood cells	8.34 ± 2.66	7.51 ± 1.42	8.24 ± 2.30	0.181
Neutrophils	5.67 ± 2.61	4.85 ± 1.38	5.65 ± 1.99	0.134
HbA1c (%)	8.46 ± 1.66	8.00 ± 1.52	8.61 ± 1.71	0.203
LDL (mmol/L)	2.60 ± 0.70	2.56 ± 0.57	2.56 ± 0.52	0.932
HDL (mmol/L)	1.00 ± 0.30	1.10 ± 0.39	1.00 ± 0.18	0.240
TC (mmol/L)	4.62 ± 1.00	4.45 ± 0.97	4.58 ± 0.81	0.661
TG (mmol/L)	1.38 ± 0.52	1.49 ± 0.68	1.58 ± 0.56	0.233
Creatinine (mmol/L)	78.73 ± 18.62	84.69 ± 26.02	81.03 ± 20.36	0.398
History of smoking (yr)	7.45 ± 11.73	10.47 ± 16.43	7.76 ± 15.00	0.552
Hypertension Duration (yr)	5.11 ± 9.01	3.74 ± 5.97	3.53 ± 4.72	0.425
Uric acid (µmol/L)	308.61 ± 83.34	324.05 ± 98.75	338.05 ± 101.20	0.240
Diabetic retinopathy	24.19%	18.42%	16.36%	0.555
Diabetic peripheral neuropathy	96.77%	86.84%	87.27%	0.121
Diabetic kidney disease	41.94%	39.47%	50.91%	0.485
Coronary heart disease	9.68%	2.63%	1.27%	0.245
PAD	100%	100%	100%	1.000
Metformin	93.55%	89.47%	83.64%	0.233
Insulin secretagogues	14.52%	10.53%	18.18%	0.596
Acarbose	25.81%	23.68%	16.36%	0.453
Insulin	83.87%	86.84%	90.91%	0.530
ACEI/ARB	40.32%	47.37%	56.36%	0.225
CCB	27.42%	26.32%	27.27%	0.992
Diuretic	3.23%	7.89%	1.82%	0.314
SBP (mmHg)	134.01 ± 17.86	131.82 ± 16.67	137.84 ± 13.52	0.187
DBP (mmHg)	80.71 ± 9.49	78.90 ± 10.37	78.65 ± 10.84	0.503

FPG: Fasting blood glucose; HbA1c: Glycosylated hemoglobin; LDL: Low-density lipoprotein; HDL: High-density lipoprotein; TC: Total cholesterol; TG: Triglyceride; PAD: Peripheral artery disease; ACEI/ARB: Angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker; CCB: Calcium channel blocker; SBP: Systolic blood pressure; DBP: Diastolic blood pressure.

Table 2 Changes in parameters after each treatment (mean ± SD)

Parameter	Group A	Group B	Group C	P value
FPG (mmol/L)	6.37 ± 1.43	6.40 ± 1.26	6.14 ± 1.20	0.553
White blood cells	8.84 ± 3.46	7.35 ± 1.74¹	5.83 ± 1.35²	0.000
Neutrophils	6.38 ± 3.66	4.97 ± 2.00¹	3.10 ± 1.12²	0.000
Uric acid (µmol/L)	298.74 ± 71.33	294.61 ± 72.68	282.76 ± 63.40	0.444
SBP (mmHg)	126.37 ± 9.39	123.07 ± 10.60	124.27 ± 11.15	0.272
DBP (mmHg)	75.23 ± 5.84	73.76 ± 6.50	73.91 ± 4.56	0.325
PCT (mmol/L)	0.72 ± 0.95	0.36 ± 0.45¹	0.05 ± 0.07²	0.000
HbA1c (%)	6.74 ± 0.87	6.76 ± 0.72	6.81 ± 0.52	0.855
LDL (mmol/L)	2.29 ± 0.48	2.27 ± 0.47	2.44 ± 0.46	0.141
HDL (mmol/L)	0.83 ± 0.26	0.74 ± 0.24	0.77 ± 0.22	0.136
TG (mmol/L)	2.63 ± 0.70	2.51 ± 0.82	2.57 ± 0.56	0.683
TC (mmol/L)	4.47 ± 0.53	4.49 ± 0.70	4.43 ± 0.62	0.901
ABI	0.76 ± 0.09	0.79 ± 0.08	0.81 ± 0.08²	0.032
TcPO₂ (mmHg)	35.56 ± 10.13	46.32 ± 8.83¹	48.19 ± 8.35²	0.000
Total amputations	1.23 ± 1.14	0.63 ± 0.63¹	0.16 ± 0.37²	0.000
Mortality rate	4.84%	0.00%	0.00%	0.102
Cardiovascular event rate	8.06%	0.00%¹	0.00%²	0.020
Hospitalization rate	62.90%	26.32%¹	5.45%²	0.000
Reamputation rate	58.06%	28.95%¹	1.82%²	0.000
Major amputation rate	69.35%	31.58%¹	36.40%²	0.000
Minor amputation rate	53.23%	31.58%¹	14.55%²	0.000
Heal rate	14.52%	65.79%¹	89.09%²	0.000
Improve rate	85.48%	36.84%¹	10.91%²	0.000
Ulcer area (cm²)	3.74 ± 2.04	2.68 ± 1.96¹	1.77 ± 1.21²	0.000
Diabetic foot surgery class	3.01 ± 0.64	2.08 ± 0.92¹	1.49 ± 0.96²	0.000

¹Group A vs group B: P < 0.05.

²Group A vs group C: P < 0.05.

FPG: Fasting blood glucose; HbA1c: Glycosylated hemoglobin; LDL: Low-density lipoprotein; HDL: High-density lipoprotein; TC: Total cholesterol; TG: Triglyceride; CCB: Calcium channel blocker; SBP: Systolic blood pressure; DBP: Diastolic blood pressure; ABI: Ankle-brachial pressure; TcPO₂: Transcutaneous oxygen pressure; PCT: Procalcitonin.

Table 3 Relationships of all the parameters with the amputation rates after treatment

Parameter	Total amputation	Major amputation	Minor amputation
R index
FPG	-0.006	0.029	-0.053
White blood cells	0.785^a	0.709^a	0.566^a
Neutrophils	0.779^a	0.699^a	0.567^a
Uric acid	0.094	0.099	0.06
SBP	0.102	0.072	0.085
DBP	0.1	0.102	0.063
PCT	0.790^a	0.713^a	0.577^a
HbA1c	0.042	-0.002	0.081
LDL	-0.203
HDL	0.101	0.091	0.07
TG	0.06	0.008	0.098
TC	-0.041	-0.085	0.013
ABI	-0.646^a	-0.516^a	-0.552^a
TcPO₂	-0.650^a	-0.537^a	-0.528^a
Ulcer area	0.261^a	0.304^a	0.103
Mortality rate	-0.155
Cardiovascular event rate	0.019	0.01	0.12
Hospitalization rate	0.726^a	0.644^a	0.542^a
Reamputation rate	0.765^a	0.678^a	0.572^a
Diabetic foot surgery class	0.309^a	0.334^a	0.15
Major amputation rate	0.852^a	1	0.357^a
Minor amputation rate	0.787^a	0.357^a	1
Heal rate	-0.436^a	-0.355^a	-0.378^a
Total number of amputations	1	0.852^a	0.787^a
Improve rate	0.426^a	0.347^a	0.370^a

^aP < 0.05.

Table 4 Logistic regression analyses of total amputation after treatment

Total amputation	B	S.E.	df	P value	95% confidence interval	OR
Neutrophils	0.003	0.042	1.000	0.936	-0.886	0.080
White
ABI	0.081	0.043	1.000	0.064	-0.171	1.867
TcPO₂	-2.407	0.455	1.000	0.000	-2.251	-5.285
PCT	-0.023	0.004	1.000	0.000	-0.015	-6.157
	0.458	0.096	1.000	0.000	0.268-0.648	4.760

The total amputation rate was positively correlated with the white blood cell count and procalcitonin (PCT) and negatively correlated with the ankle-brachial pressure (ABI) and transcutaneous oxygen pressure (TcPO₂). The strengths of the correlations were ordered as follows: TcPO₂ > ABI > PCT > white blood cell count. OR: Odd ratio; ABI: Ankle-brachial pressure; TcPO₂: Transcutaneous oxygen pressure; PCT: Procalcitonin.

Table 5 Logistic regression analyses of major amputation after treatment

Major amputation	B	S.E.	df	P value	95% confidence interval	OR
ABI	-0.892	0.411	1.000	0.032	-1.624	-2.170
TcPO₂	-0.011	0.003	1.000	0.001	0.062	-3.277
Neutrophils	-0.005	0.038	1.000	0.896	-0.150	-0.131
White	0.061	0.039	1.000	0.119	-0.154	1.570
PCT	0.293	0.087	1.000	0.001	0.122-0.465	3.378

Major amputation was positively correlated with procalcitonin (PCT) and negatively correlated with the ankle-brachial pressure (ABI) and transcutaneous oxygen pressure (TcPO₂), and the order of significance was PCT > TcPO₂ > the ABI. OR: Odd ratio; ABI: Ankle-brachial pressure; TcPO₂: Transcutaneous oxygen pressure; PCT: Procalcitonin.

Table 6 Logistic regression analyses of minor amputation after treatment

Minor amputation	B	S.E.	df	P value	95% confidence interval	OR
ABI	-1.558	0.411	1.000	0.000	-3.117	-3.791
TcPO₂
Neutrophils	-0.012	0.003	1.000	0.001	-0.024	-3.470
White	0.008	0.038	1.000	0.843	-0.149	0.198
PCT	0.015	0.039	1.000	0.696	-0.159	0.391
	0.177	0.087	1.000	0.044	0.005-0.348	2.033

Minor amputation was positively correlated with procalcitonin and negatively correlated with the ankle-brachial pressure (ABI) and transcutaneous oxygen pressure (TcPO₂), with the correlation strengths of ABI and TcPO₂ > procalcitonin. OR: Odd ratio; ABI: Ankle-brachial pressure; TcPO₂: Transcutaneous oxygen pressure; PCT: Procalcitonin.

Citation: Wang XQ, Pu DL, Leng WL, Lei XT, Juan J, La Z, Yao D, Xi JZ, Jian L, Miao T, Wu QN. Efficacy of Huangma Ding or autologous platelet-rich gel for the diabetic lower extremity arterial disease patients with foot ulcers. World J Diabetes 2024; 15(5): 923-934
URL: https://www.wjgnet.com/1948-9358/full/v15/i5/923.htm
DOI: https://dx.doi.org/10.4239/wjd.v15.i5.923