Bioresorbable Glass Fiber Matrix for Foot Ulcers

(BGWM Trial)

No longer recruiting at 14 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a bioresorbable glass fiber matrix in treating diabetic foot wounds. It compares this matrix, used with the MIRRAGEN™ dressing, to a common treatment involving the FIBRACOL™ dressing. The goal is to determine which treatment more effectively heals foot ulcers. Participants must have diabetes and a foot ulcer that hasn't healed in 4 weeks despite treatment. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment approach.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or certain doses of corticosteroids, you may be excluded from participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the special glass fiber used for treating diabetic foot ulcers is safe. In one study, patients' wounds healed better, and the treatment caused no negative side effects. This indicates that the treatment was well-tolerated and did not cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the Bioresorbable Glass Fiber Matrix for foot ulcers because it introduces a novel approach by using bioresorbable glass fibers, which naturally dissolve in the body, potentially reducing the need for dressing changes. Unlike traditional treatments that rely heavily on moisture retention dressings or collagen-based products like FIBRACOL™, this matrix actively supports wound healing by gradually resorbing and integrating into the tissue. This innovative mechanism could lead to more efficient healing processes, particularly for challenging diabetic foot ulcers, offering a promising alternative to current standard care options.

What evidence suggests that this trial's treatments could be effective for diabetic foot wounds?

Research has shown that adding the Bioresorbable Glass Fiber Matrix, which participants in this trial may receive as part of the SOC primary dressing with MIRRAGEN™, to standard diabetic foot ulcer treatment improves wound healing. One study found that patients using this matrix healed more effectively and experienced no side effects. The body absorbs the matrix, which naturally aids in tissue repair. Early results suggest this method holds promise for those with hard-to-heal diabetic foot ulcers. This treatment is designed to enhance the body's natural healing process, offering a new option for patients with these stubborn wounds. ^{2 3 4 6 7}

Who Is on the Research Team?

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

Charles M Zelen, DPM

Principal Investigator

Professional Education and Research Institute

Are You a Good Fit for This Trial?

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.

A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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 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 in conjunction with offloading and additional (outer) dressing application with 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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06403605

Bioresorbable Glass Fiber Matrix in the Treatment of ... This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available SOC treatments for DFUs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9013587/

A multi‐centre, single‐blinded randomised controlled ... Adding BBGFM to SOC significantly improved wound healing with no adverse events related to treatment compared with SOC alone.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03398538

Resorbable Glass Fiber Matrix in the Treatment of Diabetic ... This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available SOC treatments for DFUs.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12475973/

A Borate‐Based Bioactive Glass Advances Wound Healing ... A novel advanced synthetic bioactive glass matrix was studied in patients with non‐healing diabetic foot ulcers (DFUs).

5. ctv.veeva.com ctv.veeva.com/study/bioresorbable-glass-fiber-matrix-in-the-treatment-of-diabetic-foot-ulcers

Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic ... This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available SOC treatments for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06403605

Study Details | NCT06403605 | Bioresorbable Glass Fiber ... This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available SOC treatments for DFUs.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iwj.70763

A Borate‐Based Bioactive Glass Advances Wound ... The lifetime risk of developing a diabetic foot ulcer (DFU) may exceed 34% [1], with an estimated 18.6 million people around the world ...