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Effect of Insulin on Wound Healing-A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT04390815
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Abeer AlSaweer, 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.

Condition or disease Intervention/treatment Phase
Wound Heal Drug: Insulin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Regular Insulin




Primary Outcome Measures :
  1. Area of wound healing [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with Texas 1 and 2 wound criteria

Exclusion Criteria: Texas 3 and 4 wound criteria

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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    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected IPD will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 4 months

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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:
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Wounds and Injuries
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs