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Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers

NCT05797285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-02-23

No results posted yet for this study

Summary

The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®. In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either weekly or bi-weekly to the target wound. Researchers will compare how weekly or bi-weekly application of ProgenaMatrix affects the healing of DFUs.

The primary questions to be answered are:

1. How many patients achieve wound closure in 12 weeks with ProgenaMatrix treatment? And
2. What is the change in wound area during the trial in each group?

Conditions

  • Ulcer Healing
  • Diabetic Foot Ulcer

Interventions

DEVICE

human keratin graft

The intervention to be applied is an advanced wound care matrix composed of human keratin to be applied at two different treatment frequencies.

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • ProgenaCare Global, LLC

    lead INDUSTRY

Principal Investigators

  • David G Armstrong, DPM,MD,PhD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2023-12-20
Completion
2023-12-20
FDA Device
Yes

Countries

  • United States

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 NCT05797285 on ClinicalTrials.gov