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Keratin-based Skin Substitute Matrix

Weekly Human Keratin Graft Application for Foot Ulcer

N/A

Waitlist Available

Research Sponsored by ProgenaCare Global, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 weeks

Awards & highlights

Study Summary

This trial will test how a skin substitute matrix can help heal diabetic foot ulcers when applied weekly or bi-weekly.

Eligible Conditions

Foot Ulcer
Ulcer Healing

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Wound Closure

Secondary outcome measures

Change in Peripheral Neuropathy

Change in Quality of Life

Change in Wound Pain

+2 more

Other outcome measures

Number of Adverse Events Observed

Presence of Cellulitis and Infection

Trial Design

2Treatment groups

Experimental Treatment

Group I: Weekly Human Keratin Graft ApplicationExperimental Treatment1 Intervention

Patients randomized into this arm will receive standard of care (offloading, debridement, and three-layer outer dressing) with the test material, the human keratin graft, reapplied weekly to the target wound.

Group II: Bi-Weekly Human Keratin Graft ApplicationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

human keratin graft

2023

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ProgenaCare Global, LLCLead Sponsor

1 Previous Clinical Trials

100 Total Patients Enrolled

1 Trials studying Foot Ulcer

100 Patients Enrolled for Foot Ulcer

Professional Education and Research InstituteOTHER

13 Previous Clinical Trials

1,042 Total Patients Enrolled

12 Trials studying Foot Ulcer

1,013 Patients Enrolled for Foot Ulcer

David G Armstrong, DPM,MD,PhDStudy ChairUniversity of Southern California

Media Library

ProgenaMatrix® (Keratin-based Skin Substitute Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT05797285 — N/A

Foot Ulcer Research Study Groups: Weekly Human Keratin Graft Application, Bi-Weekly Human Keratin Graft Application

Foot Ulcer Clinical Trial 2023: ProgenaMatrix® Highlights & Side Effects. Trial Name: NCT05797285 — N/A

ProgenaMatrix® (Keratin-based Skin Substitute Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05797285 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for prospective participants to join this research?

"Clinicaltrials.gov indicates that this medical study is actively accepting patients, having first been published on February 28th 2023 with the most recent update being March 21st 2023."

Answered by AI

How many individuals are currently participating in this research endeavor?

"Affirmative. Clinicaltrials.gov has detailed that this trial is currently seeking enrolment, with an original post date of February 28th 2023 and the most recent update on March 21st 2023. The endeavour requires 26 patients to be found across 3 sites for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05797285.