Post marketing surveillance on safety and effectiveness of ANGIPARS in treatment of diabetic foot ulcers

Abstract

Background and the purpose of the study:One of the most important complications of diabetes is foot ulcers with a life time risk of 15% among diabetics. The main objectives of this study was to evaluate adverse drug reactions(ADR) of oral and topical application of ANGIPARS, a novel compound applied in treatment of diabetic foot ulcers and also its effect on wound surface area, Ankle Brachial Index(ABI), Toe Brachial Index(TBI) and wound temperature .

Material and Methods: A total number of 75 diabetic patients who were over 50 years (56.7± 9.7 years) and had foot ulcers without any signs of osteomyelitis were enrolled in this study. A basal wound surface area, ABI, TBI and wound temperature was measured and routine hematological and biochemistry tests were performed. Six weeks and 6 months after simultaneous application of oral and topical forms of ANGIPARS, mentioned parameters were evaluated again and analysis was carried out using standard methods.

Results and Conclusion: The mean surface area of the ulcers were 6.05 ± 11.1 cm2 at the baseline and 2.4±6.9 cm2 after six weeks of therapy showing a considerable decrease. A significant rise in ABI and TBI (p<0.05) was observed after 6 weeks of treatment. The results also demonstrated a significant fall in erythrocyte sedimentation rate (ESR) for 45 days after drug administration but no significant changes in the other laboratory tests were observed at this time. No significant side effects or toxicity was reported by the participants during the course of the study. This study showed the immense effect and safety of ANGIPARS on treatment of diabetic foot ulcers.