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Completed

NCT Number: NCT07432581

Topical Insulin Dressing on Management of Diabetic Foot Ulcers

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

normal saline

Drug

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

Primary outcomes

  1. Rate of diabetic foot ulcer healing

    Time frame: 12 weeks after the treatment

    Rate of diabetic foot ulcer healing was recorded.

Secondary outcomes

  1. Need for surgical debridement

    Time frame: 12 weeks after the treatment

    The need for surgical debridement was recorded.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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