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

16-4-2023

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.

2023-04-16

2024-06-01

2024-07-10

Active (not recruiting)

74

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 parallel groups, one treated with conventional povidone iodine 10% and the other is treated with topical insulin', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 74, 'type': 'ACTUAL'}}

2024-05-06