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NCT05797285 · ClinicalTrials.gov registry record · NA

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

A NA study of Diabetic Foot Ulcer and Ulcer Healing, sponsored by ProgenaCare Global.

Completed
Registry status
NA
Development phase
26
Enrollment target
3
Study locations

NCT05797285 is a NA study of Diabetic Foot Ulcer and Ulcer Healing that has completed, run by ProgenaCare Global. The registered enrollment target is 26 participants, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT05797285, a NA study of Diabetic Foot Ulcer and Ulcer Healing, has completed, sponsored by ProgenaCare Global.

COMPLETED
Registry status
NA
Development phase
26 participants
Enrollment target
3
Study locations

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?

Interventions

  • DEVICE human keratin graft

Study Locations (3)

Florida

  • Doctors Research Network - Miami

Maryland

  • Foot and Ankle Specialists of the Mid-Atlantic (FASMA) - Frederick

Virginia

  • Foot and Ankle Specialists of the Mid-Atlantic (FASMA) - Salem

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2023-02-28
Est. Completion 2023-12-20
Phase NA

Sponsor

ProgenaCare Global

2 total trials

What the Registry Record Tells You About NCT05797285

The ClinicalTrials.gov registry entry for NCT05797285 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (90% lower). The listed sponsor is ProgenaCare Global, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 1 intervention - of which human keratin graft is the first listed.

NCT05797285 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Maryland, Virginia.

Frequently Asked Questions

What is clinical trial NCT05797285 about?

NCT05797285 is a clinical study titled "Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers". 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 weekl...

What is the current status of trial NCT05797285?

This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2023-02-28. Estimated completion is 2023-12-20.

What conditions does trial NCT05797285 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcer, Ulcer Healing.

What interventions are being tested in trial NCT05797285?

The interventions under investigation include: human keratin graft (DEVICE).

Who is sponsoring clinical trial NCT05797285?

This trial is sponsored by ProgenaCare Global, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05797285 being conducted?

This trial has 3 study locations across Florida, Maryland, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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