Topical Insulin Dressing on Management of Diabetic Foot Ulcers

February 21, 2026 updated by: Ahmed Magdy Mohamed Ahmed, Cairo University

Topical Insulin Dressing on Management of Diabetic Foot Ulcers, Would it Help?

This study aimed to find out the advantages of topical insulin in the management of diabetic foot ulcers over the conventional wound saline dressing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non healing foot ulcers constitute a major problem that plagues those with diabetes due to angiopathy and neuropathy. It is well known that the basic cellular and molecular mechanisms that result in wound healing involve cell adhesion, migration, proliferation, differentiation, and apoptosis.

The molecular mechanisms of insulin signaling and its metabolic effects have been well studied in its classical target tissues. Insulin stimulates the growth and development of different cell types and affects proliferation, migration, and secretion by keratinocytes, endothelial cells, and fibroblasts.

Study Type

Interventional

Enrollment (Actual)

30

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, 12613
        • Cairo University

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with diabetes between the age group 18-85 years.
  • Both sexes.
  • Patients who were diagnosed with diabetic foot according to the 2010 Edition of the Clinical Practice Guidelines for the Prevention and Management of Diabetes Foot Complications (edited by the American Diabetes Association) presented to diabetic foot clinic on regular basis.
  • Participants who were able to and willing to participate in the study voluntarily who could come for dressings on a daily basis, or patients who agreed for admission for the duration of treatment were included in the study.
  • Patients having ulcer below the ankle on the dorsal or plantar aspect of the foot.
  • Patients with grade I and grade II ulcers of Wegener's Classification without significant growth of granulation tissue.
  • Patients with controlled blood glucose levels between 110 and 130 gm/dl. Hemoglobin A1c was 7.1 ± 0.34.
  • Non heavely infected wounds without significant growth of granulation tissue.

Exclusion Criteria:

  • Patients with diabetic foot ulcers of Wagner grade V.
  • X-ray showing features of osteomyelitis.
  • Duplex showing significant atherosclerotic changes and venous abnormalities like varicosities.
  • Malnutrition and uncontrolled diabetes mellitus.
  • Other clinically significant medical conditions that would impair wound healing like any hepatic, renal, immunological and neurological disease and coagulopathy.
  • Patients receiving corticosteroids, other immunosuppressive agents, radiation or chemotherapy one month prior to entry into the study.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (soluble insulin (Actrapid))
The ulcers were cleaned with normal saline and then irrigated with 4 units (0.1 ml) of human soluble insulin (Actrapid) in 1 ml normal saline (0.9%) for every 10 cm square of the wound.
Drug: Insulin
The ulcers were cleaned with normal saline and then irrigated with 4 units (0.1 ml) of human soluble insulin (Actrapid) in 1 ml normal saline (0.9%) for every 10 cm square of the wound.
Active Comparator: Group B (normal saline)
The ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes
Drug: Normal saline
The ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of diabetic foot ulcer healing
Time Frame: 12 weeks after the treatment
Rate of diabetic foot ulcer healing was recorded.
12 weeks after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for surgical debridement
Time Frame: 12 weeks after the treatment
The need for surgical debridement was recorded.
12 weeks after the treatment

Collaborators and Investigators

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

Sponsor

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)

January 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

February 14, 2026

First Submitted That Met QC Criteria

February 21, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-85-2023 (1-6-2023)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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