Evaluation of a Polyherbal Topical Formulation versus Silver Sulfadiazine in the Management of Diabetic Foot Ulcers: A Randomized Pilot Study

Background:Diabetic foot ulcers (DFUs) remain a leading cause of non traumatic lower limb amputationsworldwide, particularly in low- and middle income countries, contributing substantially tomorbidity, mortality, and healthcare costs. Despite advances in wound care, the need for costeffective and accessible therapeutic alternatives persists. This study aimed to evaluate the safetyand therapeutic efficacy of a polyherbal topical formulation in comparison with silversulfadiazine cream in patients with type 2 diabetes mellitus.Methods:In this randomized, controlled pilot study, 40 patients with type 2 diabetes and clinicallydiagnosed foot ulcers were enrolled and allocated into two groups (n = 20 each). Group I receivedthe polyherbal topical formulation, while Group II was treated with silver sulfadiazine cream.Patients were followed for a period of 5 months. Baseline ulcer characteristics, including lengthand width, were documented, and serial wound assessments were conducted using standardizedphotographic and clinical evaluation methods. The primary endpoint was time to completewound healing, while secondary endpoints included percentage reduction in ulcer size and safetyoutcomes.Results:Baseline demographic and clinical parameters, including age, duration of diabetes, and glycemicstatus (HbA1c), were comparable between the groups. Initial ulcer dimensions showed nostatistically significant differences. Both treatment arms demonstrated significant reductions inwound size over time (P < 0.001). The mean time to complete wound healing was approximately45 days in both groups, with no statistically significant intergroup difference. Importantly, noserious adverse events or treatment related complications were observed in either group.Conclusions:The polyherbal topical formulation exhibited comparable efficacy and safety to silversulfadiazine in the management of diabetic foot ulcers. These findings highlight the potential ofpolyherbal therapy as a cost effective, culturally acceptable, and accessible alternative,particularly in resource-constrained settings. Nevertheless, larger, multi center randomizedcontrolled trials with extended follow up are required to validate these preliminary findings andelucidate underlying mechanisms of action