Evaluation of Comparative Efficacy of Arjunadi Ointment versus Cadexomer Iodine Ointment on Wound Healing of Madhumehjanya Dushta Vrana (Diabetic Foot Ulcer): A Clinical Trial Protocol

Introduction: Diabetic foot ulcers are one of the most common complications associated with diabetes and are linked to poor glycaemic control, peripheral neuropathy, and vascular disease. Chronic wounds, most often found on the soles of the feet, are the leading cause of lower extremity amputations globally. Traditional treatments primarily focus on infection control and wound closure but often fail to address the complex physiological and pathological processes involved in healing. The present randomised, single-blind, double-arm clinical study compares the effectiveness of Arjunadi ointment, a polyherbal formulation from Ayurveda, with that of Cadexomer iodine ointment in managing diabetic foot ulcers. Aim: To compare the efficacy of Arjunadi and Cadexomer iodine ointments in diabetic foot ulcer healing, integrating Ayurvedic principles with modern clinical methods for comprehensive management. Need of the study: Diabetic foot ulcers affect nearly 15% of individuals with diabetes, often leading to complications such as infections, osteomyelitis, and amputations. While conventional treatments primarily target infection control, other aspects of wound care remain unmet. Arjunadi ointment offers a holistic healing approach with anti-inflammatory, antimicrobial, and analgesic properties. Materials and Methods: The present randomised, singleblind, double-arm trial will take place in the outpatient and inpatient Departments of Shalya Tantra at Mahatma Gandhi Ayurveda Hospital, Wardha, Maharashtra, India. The study will include 30 participants aged 30-70 years with chronic diabetic nonhealing foot ulcers persisting for over four weeks. The study is expected to commence in February 2026. Participants are divided into two groups: Group A, treated with Cadexomer iodine ointment, and Group B, treated with Arjunadi ointment. Ointments will be applied twice daily for 30 days, supplemented with standard antidiabetic drugs and antibiotics. Wound healing is evaluated on days 0, 15, and 30 using the BatesJensen Wound Assessment Scale (BJWAS). Statistical analysis, including paired and unpaired t-tests, will determine treatment efficacy. The study trial lasts three months, including a followup evaluation on the 60th day after treatment