Effect of Insulin on Wound Healing-A Randomized Controlled Trial

NCT04390815 | Unknown Phase 4

• 1 other identifier: IWCT20
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Insulin DRUG

Adding insulin to conventional wound treatment

Also known as: Regular Insulin

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with Texas 1 and 2 wound criteria

Sponsors & Collaborators

• Ministry of Health, Bahrain: lead

Related Publications (1)

• 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.

  PMID: 35667792 DERIVED

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Central Diabetes clinic coordinator in PHC

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 18, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 4 months