Bioresorbable Glass Fiber Matrix for Foot Ulcers

(BGWM Trial)

Recruiting at 13 trial locations

Overseen By Donald W Buck II, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ETS Wound Care, LLC

Must not be taking: Immunosuppressants, Cytotoxic chemotherapy

Disqualifiers: Infection, Osteomyelitis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Charles M Zelen, DPM

Principal Investigator

Professional Education and Research Institute

Robert Galiano, MD

Principal Investigator

Professor of Surgery, Plastic Surgery, Northwestern University School of Medicine, Chicago, IL

David Armstrong, DPM, MD, PhD

Principal Investigator

USC/Salsa

Eligibility Criteria

Adults over 18 with type 1 or 2 diabetes and a foot ulcer not probing to bone can join. The ulcer must be on the foot, present for 4-52 weeks, sized between 1.0-20.0 cm² after debridement, and offloaded for at least two weeks if plantar. Good blood flow to the foot is required; severe kidney disease, recent investigational drug use, pregnancy plans within six months, high HbA1c levels (>12%), or certain treatments like hyperbaric oxygen in the past month are disqualifiers.

Inclusion Criteria

My foot or ankle ulcer is deep but does not reach the bone.

I have been diagnosed with type 1 or type 2 diabetes.

I have at least two ulcers, each more than 2 cm apart.

Exclusion Criteria

My target ulcer is not infected, and there's no cellulitis around it.

My target ulcer has not shrunk by more than 30% in the last 2 weeks.

I am on dialysis for end-stage kidney disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either MIRRAGEN™ Advanced Wound Matrix or FIBRACOL™ dressing for diabetic foot ulcers, with offloading and additional dressing application

12 weeks

Weekly visits for wound assessment and treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bioresorbable Glass Fiber Matrix

Trial Overview The trial compares two standard-of-care wound treatments: Fibracol and Mirragen Wound Matrix for diabetic foot ulcers. It's a prospective study where patients are randomly assigned to either treatment group across multiple centers.

Participant Groups

Group I: SOC primary dressing with MIRRAGEN™ Experimental Treatment 1 Intervention

Mirragen Wound Matrix MIRRAGEN™ Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix 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: SOC primary dressing with FIBRACOL™ Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

ETS Wound Care, LLC

Lead Sponsor

Trials

2

Recruited

140+

Professional Education and Research Institute

Collaborator

Trials

16

Recruited

1,400+