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Wound Dressing

Mirragen Wound Matrix Dressing for Diabetic Foot

N/A
Waitlist Available
Led By David Armstrong, DPM, MD, PhD
Research Sponsored by ETS Wound Care, 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 6 and 12 weeks
Awards & highlights

Study Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC dressings treatments for Diabetic Foot Wounds

Eligible Conditions
  • Diabetic Foot
  • Foot Ulcer
  • Venous Leg Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 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
Percentage of index ulcers healed at 12 weeks
Secondary outcome measures
Change in pain levels during trial, using the FACES pain scales which measure pain on a range of 0-10, zero being no pain and 10 being the most severe pain
Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10"point discrimination test
Injury wounds
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mirragen Wound Matrix DressingExperimental Treatment3 Interventions
MIRRAGEN™ Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix dressing to be used per manufacturer instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing
Group II: Fibracol Wound DressingActive Control3 Interventions
A commercially available wound dressing to be used per manufacturer's instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing

Find a Location

Who is running the clinical trial?

Professional Education and Research InstituteOTHER
13 Previous Clinical Trials
1,028 Total Patients Enrolled
12 Trials studying Diabetic Foot
999 Patients Enrolled for Diabetic Foot
ETS Wound Care, LLCLead Sponsor
David Armstrong, DPM, MD, PhDPrincipal InvestigatorUSC / Salsa
6 Previous Clinical Trials
515 Total Patients Enrolled
4 Trials studying Diabetic Foot
462 Patients Enrolled for Diabetic Foot

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
2017. "Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03398538.
~6 spots leftby Apr 2025
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