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Effect of Insulin on Wound Healing-A Randomized Controlled Trial

Sponsor
Ministry of Health, Bahrain (Other)
Overall Status
Unknown status
CT.gov ID
NCT04390815
Collaborator
(none)
30
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Effect of Insulin on Wound Healing- A Randomized Controlled Trial
Anticipated Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients with Texas 1 and 2 wound criteria

    Exclusion Criteria: Texas 3 and 4 wound criteria

    -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ministry of Health, Bahrain

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abeer AlSaweer, Central Diabetes clinic coordinator in PHC, Ministry of Health, Bahrain
    ClinicalTrials.gov Identifier:
    NCT04390815
    Other Study ID Numbers:
    • IWCT20
    First Posted:
    May 18, 2020
    Last Update Posted:
    May 19, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Wounds and Injuries
    Insulin
    Insulin, Globin Zinc

    Study Results

    No Results Posted as of May 19, 2020