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SOC primary dressing with MIRRAGEN™ for Diabetic Foot (BGWM Trial)

Q: In how many medical facilities is this examination being conducted?

<p>Wound Care Experts in Las Vegas, <a href="https://www.withpower.com/clinical-trials/nevada">Nevada</a>; Foot and Ankle Specialists of the Mid Atlantic in Salem, <a href="https://www.withpower.com/clinical-trials/virginia">Virginia</a>; and Casa Colina in Pomona, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> are some of the sites where patients can enroll for this trial. Additionally, there are 14 more locations participating in patient recruitment.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 weeks

Awards & highlights

BGWM Trial 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.Check my eligibility

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.See study design

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.

BGWM Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

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

Select...

My foot ulcer is mostly below my ankle.

Select...

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

Select...

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

Select...

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

BGWM Trial 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

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 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 outcome measures

Difference in cellulitis and/or infection

Use of near-infrared tissue oxygenation imaging

BGWM 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 / 6Eligibility 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 Diabetic Foot

40 Patients Enrolled for Diabetic Foot

Professional Education and Research InstituteOTHER

14 Previous Clinical Trials

1,068 Total Patients Enrolled

13 Trials studying Diabetic Foot

1,039 Patients Enrolled for Diabetic Foot

Robert Galiano, MDStudy ChairProfessor of Surgery, Plastic Surgery, Northwestern University School of Medicine, Chicago, IL

5 Previous Clinical Trials

480 Total Patients Enrolled

2 Trials studying Diabetic Foot

320 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.

In how many medical facilities is this examination being conducted?

"Wound Care Experts in Las Vegas, Nevada; Foot and Ankle Specialists of the Mid Atlantic in Salem, Virginia; and Casa Colina in Pomona, Florida are some of the sites where patients can enroll for this trial. Additionally, there are 14 more locations participating in patient recruitment."

Answered by AI

What is the overall patient enrollment count for this clinical trial?

"The clinical trial aims to recruit 100 eligible participants who meet the defined inclusion criteria. Potential candidates can enroll at various sites, including Wound Care Experts in Las Vegas, Nevada, and Foot and Ankle Specialists of the Mid Atlantic in Salem, Virginia."

Answered by AI