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Bioresorbable Glass Fiber Matrix for Foot Ulcers (BGWM Trial)

N/A

Recruiting

Led By Charles M Zelen, DPM

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

Subjects must be at least 18 years of age or older

Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus

Must not have

A subject with a previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer

The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 weeks

Awards & highlights

Summary

This trial will compare two different treatments for Diabetic Foot Wounds in multiple medical centers to see which one works better.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include irritation at the application site, allergic reactions to materials used in dressings or matrices, infection risk due to open wounds especially if not properly managed according to protocol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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My foot ulcer is mostly below my ankle.

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My diabetic foot ulcer is between 1.0 and 20.0 cm2 after cleaning.

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

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I agree to follow the recommended off-loading method throughout the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a foot deformity from a past partial amputation affecting ulcer healing.

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

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I am on dialysis for end-stage kidney disease.

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I am not pregnant nor planning to become pregnant in the next 6 months.

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

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I have a bone infection or exposed bone that can be felt or seen on scans.

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I am taking immunosuppressants or chemotherapy.

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I have a Charcot foot condition affecting my ulcer treatment.

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I do not have any infections requiring antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of index ulcers healed at 12 weeks

Secondary study objectives

Change in pain levels during trial, using the NPRS pain scale 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

Changes in wound quality of life using Wound-Q

+3 more

Other study objectives

Difference in cellulitis and/or infection

Use of near-infrared tissue oxygenation imaging

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SOC primary dressing with MIRRAGEN™Experimental Treatment1 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 Control1 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

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

ETS Wound Care, LLCLead Sponsor

1 Previous Clinical Trials

40 Total Patients Enrolled

1 Trials studying Foot Ulcer

40 Patients Enrolled for Foot Ulcer

Professional Education and Research InstituteOTHER

14 Previous Clinical Trials

1,068 Total Patients Enrolled

13 Trials studying Foot Ulcer

1,039 Patients Enrolled for Foot Ulcer

David Armstrong, DPM, MD, PhDStudy ChairUSC/Salsa

7 Previous Clinical Trials

555 Total Patients Enrolled

4 Trials studying Foot Ulcer

460 Patients Enrolled for Foot Ulcer

~11 spots leftby Dec 2024

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