Wound Healing Efficacy of Topical Minoxidil Dressing in Ischemic Diabetic Foot Wound - A Pilot Study

This study is a randomized, double-blind, interventional pilot study with a sample size of 30 patients, divided into two groups of 15 each.

Topical O2 therapy is added from 1st post-operative day. The wound size will be assessed on the first day and daily thereafter. On the first post-operative dressing (i.e., after 24 hours of surgery or wound cleaning), the assigned dressing protocol will begin.

For dressing, the clinical investigator will be given coded drug-filled syringes as per randomization — containing either Minoxidil or Normal saline (placebo) to be added to the standard dressing protocol. The syringe will be pre-filled and coded to maintain blinding. Neither the patient nor the dressing staff will know the contents.

Dressing Protocol:

1. The wound will be cleaned with normal saline and mopped with sterile gauze.

2. Either interventional drug i.e., Minoxidil (at the required concentration) or Normal saline will be applied as 1 ml per 2–2.5 sq. cm of wound area.

3. It will be applied topically using a 24G blunt needle and syringe.

4. The wound will be covered with sterile gauze and standard dressing.

Dressing will be changed every 24 hours up to 30 days, or until healthy granulation occurs. Wound healing progress will be assessed based on:

1. Size of wound

2. Quality of granulation – pale, pink, or red

3. Presence of exudates – Yes or No, if yes- serious or pus

4. Condition of surrounding skin – edema present or not

Daily progress will be recorded. Once healthy granulation is observed, the date will be noted. If granulation is achieved within 30 days, wound will be prepared for skin grafting or allowed to heal by secondary intention.