Randomized Double-Blind Placebo-Controlled Trial of AngiparsTM in Diabetic Foot Ulcer, Study Protocol

Abstract

Diabetes Mellitus (DM) is the most common metabolic disease in the world. About 15% of diabetic patients experience diabetic foot ulcer (DFU). Despite all the efforts in treating DFUs, the incidence of lower extremity amputations remains rather high. There are different modalities for treating this complication of DM. Angipars^TM is a novel safe herbal formulation, recently presented for treating the condition. This study presents a trial which has been designed to evaluate the efficacy and safety of Angipars^TM in treatment of DFUs in larger scale. In this randomized double-blind placebo controlled trial, a total of 300 participants (150 in each of the two arms) will be recruited from a tertiary clinic in Tehran. The patients aged between 18 and 75 years and are diagnosed with grade II or III of foot ulcer based on the Wagner's wound classification. The closure of the wound surface area is determined as the primary outcome, whereas the secondary outcome consists of ankle brachial index, toe pressure, wound bed temperature, overall clinical and patient impression of change, and the adverse effects of Angipars^TM. These factors will be measured at baseline as well as 2, 4, 6, 10 and 18 weeks after the six weeks treatment period by an individual unaware of the participants' baseline characteristics and their treatment allocation. We will also collect data and analyze intention-to-treat of our intervention. The results of this study will provide valuable new information regarding Angipars^TM, a novel herbal drug hypothesized to be effective in treating DFUs.