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Bioactive Smart Dressings for Diabetic Foot Ulcers: Randomized Controlled Trial

Diabetic Foot Ulcer Clinical Trial

Official title:
Novel Bioactive Smart Dressings for Diabetic Foot Ulcers: a Randomized Controlled Trial Comparing Efficacy of PRP-loaded Lyophilized Gel vs. Erythropoietin/Isosorbide Dinitrate Cryogel Scaffold vs. Standard of Care

Clinical Trial Summary

We propose a randomized controlled study to assess the efficacy of: 1. Platelet-lysate loaded sustained release thermo-gelling formulation (Platelets-SR) 2. EPO/ISDN/UFH cryogel dressing (Trigel) As adjuncts to standard-of-care (SOC) in the treatment of chronic DFUs compared to SOC alone for patients attending the DFU outpatient clinic at the Gastroenterology Centre, Mansoura University.

Clinical Trial Description

The tested treatments were manufactured, tested and optimized in the research laboratories of Pharmacy School, Mansoura University under ethical approval of Pharmacy School ethics committee and Medical School IRB committee. Our primary objective is to test the hypothesis that the proposed treatments can significantly improve the wound area regression rate assessed weekly (cm2/week) for 8 weeks as compared to SOC treatment alone. Our secondary objectives are to assess the following: the time to complete wound closure, the rate of complete wound closure and the rate of partial wound closure of ≥ 50% and ≥ 75% at end-of-treatment visit (week 8). Wound closure is confirmed when the wound remains closed at two follow up visits. The occurrence of any adverse effects either locally or systemically will be surveilled in order to assess the safety profile of the test formulations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05671250
Study type Interventional
Source Mansoura University
Contact
Status Completed
Phase Phase 2
Start date July 15, 2021
Completion date January 1, 2023
View Details
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