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Bioactive Smart Dressings for Diabetic Foot Ulcers: Randomized Controlled Trial

NCT05671250 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-01-04

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Toaa Ashraf · Mansoura University

  • Amira Motawea · Mansoura University

  • Marwa S. El-Dahhan · Mansoura University

  • Fady Azmy · Mansoura University

  • Galal M. Abdelghani · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2022-11-01
Completion
2023-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671250 on ClinicalTrials.gov