Topical Insulin Dressing on Management of Diabetic Foot Ulcers

NCT07432581 | Completed

• 1 other identifier: MD-85-2023 (1-6-2023)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Topical; Insulin; Dressing; Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Rate of diabetic foot ulcer healing

  Rate of diabetic foot ulcer healing was recorded.

  12 weeks after the treatment

Secondary Outcomes (1)

• Need for surgical debridement

  12 weeks after the treatment

Study Arms (2)

Group A (soluble insulin (Actrapid))

EXPERIMENTAL

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

Group B (normal saline)

ACTIVE COMPARATOR

The ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes

Drug: Normal saline

Interventions

Insulin DRUG

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.

Group A (soluble insulin (Actrapid))

Normal saline DRUG

The ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes

Group B (normal saline)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Insulin Resistance; Diabetic Foot

Interventions

Insulin; Saline Solution

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Vascular Surgery, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 25, 2026
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)