To Assess the effectiveness of topical insulin versus normal saline dressing in patients with diabetic foot ulcers: a prospective open labelled randomised controlled trial.

Chronic wounds are those that fail to heal within three months despite optimal management and are commonly seen in conditions such as diabetic foot ulcers and pressure sores. They affect millions worldwide, with a significant burden in India. Diabetic foot ulcers are particularly common in older patients and are associated with poor healing, high risk of infection, osteomyelitis, gangrene, and possible amputation. Insulin has properties that reduce inflammation, enhance collagen deposition, promote protein synthesis, and support re epithelialisation. Topical insulin has therefore emerged as a potential therapy for non healing diabetic ulcers.

This study is a prospective open labelled randomized controlled trial conducted over eighteen months in the Department of General Surgery at Mata Chanan Devi Hospital, New Delhi. It aims to evaluate the effectiveness of topical insulin dressing compared to normal saline dressing in patients with diabetic foot ulcers. The primary objective is to compare wound healing based on reduction in wound size, and the secondary objective is to compare duration of hospital stay.

A total of fifty patients will be included, with twenty five patients in each group, randomized in a one to one ratio. Group A will receive topical insulin dressing, while Group B will receive conventional normal saline dressing. Wound parameters such as size, depth, presence of slough or discharge, granulation tissue, culture results, need for grafting, need for amputation, and hospital stay will be assessed at regular intervals. Statistical analysis will be performed using appropriate tests to compare outcomes between groups. Ethical approval and informed consent will be obtained prior to the study.