Effect of ANGIPARS™, a new herbal drug on diabetic foot ulcer: A phase 2 clinical study


Abstract: Diabetes foot ulcers are a major predictor of future lower-extremity amputation in patients with diabetes. The animal studies have indicated that treatment with a new herbal extract named ANGIPARS™ improves healing of chronic ulcers. The main objective of the study was to evaluate the safety and healing rates of diabetic foot ulcers in patients treated with ANGIPARS™. Ten diabetic patients (7 males and 3 females) were eligible for enrollment in this single arm before-after clinical trial. The target wound's greatest length and width was measured at baseline. The target wound was photographed at baseline and then every two weeks. The wound area was determined by means of planimetry. The mean age of patients was 57± 2.3 years. The mean surface area of ulcers was 12.32±11 cm2, 9.55±9 cm2, and 6.96±6 cm2 at baseline, one month and two months of study, respectivly. Our results showed that the drug could reduce the wound size at least 50% during 8 weeks period. We found no adverse side effects in our patients. The main conclusion of the present study was to show the efficacy and safety of ANGIPARS™ as a novel therapy in diabetic foot ulcers. Keywords: Diabetic foot ulcer, ANGIPARS™, treatment, Phase II, Intervention