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Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

NCT06403605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-11-10

Study results available
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Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.

Conditions

  • Diabetic Foot Ulcer
  • Ulcer Foot
  • Diabetic Foot

Interventions

DEVICE

Mirragen Advanced Wound Matrix

Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Mirragen Advanced Wound Matrix - application of Mirragen to wound site along with standard of care treatment.

DEVICE

Fibracol

Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Fibracol - application of Fibracol to wound site along with standard of care treatment.

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • ETS Wound Care, LLC

    lead INDUSTRY

Principal Investigators

  • David Armstrong, DPM, MD, PhD · USC/Salsa

  • Charles M Zelen, DPM · Professional Education and Research Institute

  • Robert Galiano, MD · Professor of Surgery, Plastic Surgery, Northwestern University School of Medicine, Chicago, IL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2025-01-17
Completion
2025-01-17
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 NCT06403605 on ClinicalTrials.gov