Topical Insulin for Postoperative Wound Healing

August 20, 2024 updated by: Omnia Azmy Nabeh, Cairo University

Investigating the Impact of Topical Insulin on Postoperative Wound Healing in Diabetic and Non-Diabetic Patients: A Randomized Controlled Trial

This study aimed to investigate the potential effect of applying topical insulin therapy on the management and healing of postoperative wounds in patients known with type 2 diabetes mellitus (T2DM) and in a parallel group without diabetes. Investigators also studied the effect of topical insulin therapy on the expression of e-cadherin and Ki67, as markers for cellular proliferation and wound repair. The levels of IL-6 and the H2O2-induced DNA damage product, 8-hydroxy-2'-deoxyguanosine (8-OHdG), were assessed as markers for inflammation and oxidative stress. Finally, histomorphological assessment of skin biopsies was also carried out.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study participants will be recruited from general surgery department ,all patients with elective surgical procedure who will be admitted at the department for at least one week as it is the minimal duration of postoperative wound healing and the study will be conducted according to the regulations of ethical committee of clinical studies in the Faculty of Medicine, Cairo University

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Omnia Azmy Nabeh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both males and females
  • 40-60 years old
  • diagnosed with type 2 DM (for the diabetic trial)
  • For the diabetic trial: glycosylated hemoglobin (HBA1c) ≤7.5 %
  • haemoglobin (Hb) ≥ 12 g/dl
  • Patients who had a full thickness post-operative wound of ≥10 cm

Exclusion Criteria:

  • Those with known history of immunodeficiency, keloid formation, or hyperkeratotic skin lesion.
  • Patients who had hypersensitivity to insulin,
  • Patients with severe infection,
  • Patients with any severe organ dysfunction
  • Patients who were admitted to ICU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Povidone iodine 10%
Drug: Povidone-Iodine
Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment
Experimental: Topical insulin
Drug: Insulin
Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculation of Unit Healing Time index
Time Frame: Before and after 7 days of therapy
The total healing days and the surface area of the wound will be combined to report unit healing time in units
Before and after 7 days of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Omnia Azmy Nabeh, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-4-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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