NCT05671250

Bioactive Smart Dressings for Diabetic Foot Ulcers: Randomized Controlled Trial

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PRP gel and SOC-treatment	Platelet-lysate loaded sustained release thermo-gelling formulation
COMBINATION_PRODUCT	EPO/ISDN/UFH cryogel dressing	Erythropoietin/Isosorbide dinitrate loaded cryogel scaffold
PROCEDURE	Standard of Care	Sharp debridement, saline washing and regular saline dressing

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-11-01
• Completion: 2023-01-01
• First posted: 2023-01-04
• Last updated: 2023-01-04

Locations

1 site across 1 country: Egypt