Effect of Insulin on Wound Healing-A Randomized Controlled Trial

Phase 4

• Conditions: Wound Heal
• Interventions: Drug: Insulin

• Registration Number: NCT04390815
• Lead Sponsor: Ministry of Health, Bahrain

Brief Summary

A randomized controlled trial examining the effect of insulin on wound healing in both diabetics and non diabetic patients in a local health center in Bahrain.

Detailed Description

This is a double blinded RCT comparing the effect of insulin on wound healing in both diabetics and non diabetics.

The study will run in primary care setting in Bahrain. The aim of this study is to heal wound in an innovative way. and the Objective: to evaluate the effect of topical insulin administration on wound healing.

All adult patients with skin wounds attending primary health care center will be included in the study. Patients with acute and chronic wounds of the upper and lower extremities will be eligible to participate.

Study Timeline

• Study First Submitted: 2020-04-26
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-17
• Study First Posted: 2020-05-18
• Last Update Posted: 2020-05-19
• Study Start: 2020-08
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult patients with Texas 1 and 2 wound criteria

Exclusion Criteria

Texas 3 and 4 wound criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Insulin	Before starting the therapeutic procedure, all wounds will be fully washed with normal saline. Group A patients will receive 10 units (0.1 mL) of regular insulin (manufactured by novo nordisk) in solution with 1 cc of normal saline 0.9% for each 10 cm of wound. The solution will be sprayed on the wound surface with an insulin syringe needle, once daily. The patients in this arm will receive conventional therapy.
Control	Insulin	Before starting the therapeutic procedure, all wounds will be fully washed with normal saline Group B patients will receive conventional topical application without insulin

Primary Outcome Measures

Name	Time	Method
Area of wound healing	4 months	Rate of wound healing will be calculated as the difference between the primary and final wound area in mm as a function of healing time (in days) and reported as mm/day.