Effect of Insulin on Wound Healing-A Randomized Controlled Trial

Effect of Insulin on Wound Healing- A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Wound Heal
• Intervention / Treatment: Drug: Insulin

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients with Texas 1 and 2 wound criteria

Exclusion Criteria: Texas 3 and 4 wound criteria

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Drug: Insulin; Adding insulin to conventional wound treatment; Other Names: Regular Insulin
Placebo Comparator: Control; Before starting the therapeutic procedure, all wounds will be fully washed with normal saline Group B patients will receive conventional topical application without insulin	Drug: Insulin; Adding insulin to conventional wound treatment; Other Names: Regular Insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area of wound healing	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.	4 months

Collaborators and Investigators

• Sponsor: Ministry of Health, Bahrain

Publications and helpful links

General Publications

• Xue Y, Reddy SK, Garza LA. Toward Understanding Wound Immunology for High-Fidelity Skin Regeneration. Cold Spring Harb Perspect Biol. 2022 Jul 1;14(7):a041241. doi: 10.1101/cshperspect.a041241.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: IWCT20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all collected IPD will be shared
• IPD Sharing Time Frame: 4 months
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No