To observe the clinical effects of Traditional Chinese Medicine (TCM) Tangnaikang granules, supplementing to conventional treatment methods, on type 2 diabetic foot ulcer.

A total of 67 patients, from Beijing University of Chinese Medicine subsidiary Dongfang Hospital, Tuanjie Lake Community Health Service Center, Qingta Community Health Service Center between August, 2019 and November, 2020 were assigned to treatment group (37 patients) and control group (30 patients) using sealed envelope randomization method. The control group underwent conventional treatment methods that manage blood sugar and treat infections. The treatment group received, in addition to the conventional treatment methods administered to the control group, Tangnaikang granules. Both groups were continuously treated for 90 days. The TCM symptom scores, granulation tissue scores, visual analogue scale (VAS), itching scores and Generic Quality of Life Inventory-74 (GQOL-74) score, wound area were observed pre- and post-treatment. The ELISA kits were used to detect the Vascular Endothelial Growth Factor (VEGF), Epidermal Growth Factor (EGF), Basic Fibroblast Growth Factor (bFGF), fasting blood glucose level, glycated hemoglobin test (HbA1c), fasting insulin level, postprandial 2 hour insulin level, insulin resistance index. And all possible adverse events were noted. The overall clinical treatment effects and TCM symptom treatment effects were assessed.

Total effective rate for the treatment group 89.2% (33/37), was significantly different from that of the control group 70.0% (21/30) with χ²=3.90 and P<0.01. The TCM symptom effective rate was 86.5% (32/37) for the treatment group and 63.3% (19/30) for the control group. The difference was statistically different with χ²=4.88 and P<0.01. After treatment, whole blood viscosity, plasma viscosity, fibrinogen and erythrocyte sedimentation rate (ESR) of the treatment group were significantly improved than those of the control group (t=-23.38, -8.01, 18.10, -18.93,all Ps<0.01). The ulcer closure area (5.43±1.65 cm²vs. 4.65±1.14 cm², t=2.20) and ulcer closure area percentage (59.14%±3.37% vs. 42.42%±3.21%，t=20.63) were statistically different of both groups (P<0.05 or P<0.01). The VEGF, EGF, and bFGF at 90 day of the treatment group were significantly higher than those of the control group (t=3.19, 40.59, 28.53, all Ps<0.01). The post-treatment fasting blood glucose level, insulin resistance index of the treatment group were significantly lower than those of the control group (t=-8.55, -21.38, all Ps<0.01). TCM symptoms of thirsty, feverish sensation in chest, palms and soles in the treatment group were significantly improved than the control group (χ²=4.38, 4.48, all Ps<0.01).

TCM compound Tangnaikang granules can relieve diabetic foot ulcer, reduce wound healing time and improve overall treatment outcome, when it was combined of the conventional treatment.

Diabetic foot; Diabetes mellitus, type 2; Tangnaikang granules; Integrated Chinese traditional and western medicine therapy