Topical Insulin for Postoperative Wound Healing

NCT06400082 | Active Not Recruiting DMC

• 1 other identifier: 16-4-2023
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Complication; Insulin Resistance, Diabetes

Outcome Measures

Primary Outcomes (1)

• Calculation of Unit Healing Time index

  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

Study Arms (2)

Povidone iodine 10%

ACTIVE COMPARATOR

Drug: Povidone-Iodine

Topical insulin

EXPERIMENTAL

Drug: Insulin

Interventions

Insulin DRUG

Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

Topical insulin

Povidone-Iodine DRUG

Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

Povidone iodine 10%

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both males and females
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Omnia Azmy Nabeh

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus

Interventions

Insulin; Povidone-Iodine

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Omnia Azmy Nabeh, MD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 2 parallel groups, one treated with conventional povidone iodine 10% and the other is treated with topical insulin

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 6, 2024
• Study Start: April 16, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 10, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

EG (1)