Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

NCT06403605 | Completed Results FDA Device

• 1 other identifier: ETS-MG-DFU-02
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

DFU; Ulcer

Outcome Measures

Primary Outcomes (1)

• Complete Wound Healing

  The proportion of subjects achieving complete wound closure.

  12 weeks

Secondary Outcomes (4)

• Percentage Area Reduction (PAR)

  12 weeks

• Time to Heal

  12 weeks

• Changes in Quality of Life

  12 weeks

• Change in Pain Level

  12 weeks

Study Arms (2)

SOC primary dressing with MIRRAGEN™

EXPERIMENTAL

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.

Device: Mirragen Advanced Wound Matrix

SOC primary dressing with FIBRACOL™

ACTIVE COMPARATOR

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.

Device: Fibracol

Interventions

Mirragen Advanced Wound Matrix DEVICE

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.

SOC primary dressing with MIRRAGEN™

Fibracol DEVICE

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.

SOC primary dressing with FIBRACOL™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be at least 18 years of age or older.
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with a photographic planimetry app.
• The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
• The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
• Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
• TCOM ≥30 mmHg
• ABI between 0.7 and 1.3
• PVR: Biphasic
• TBI ˃0.6
• As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle

You may not qualify if:

• Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.
• The subject must consent to using the prescribed off-loading method for the duration of the study.
• The subject must agree to attend the weekly study visits required by the protocol.
• The subject must be willing and able to participate in the informed consent process.
• A subject known to have a life expectancy of \< 6 months is excluded.
• If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
• Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
• A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
• A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• If a subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.
• If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
• 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: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.
• A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.

Sponsors & Collaborators

• ETS Wound Care, LLC: lead
• Professional Education and Research Institute: collaborator

Study Sites (15)

LA Foot and Ankle

Los Angeles, California, 90010, United States

Location

Casa Colina

Pomona, California, 91769, United States

Location

Center for Clincal Research

San Francisco, California, 94115, United States

Location

Southernmost Foot and Ankle Specialists

Homestead, Florida, 33030, United States

Location

Doctor's Research Network

South Miami, Florida, 33143, United States

Location

Gateway Clinical Trials

O'Fallon, Illinois, 62269, United States

Location

Foot and Ankle Center of Illinois

Springfield, Illinois, 62704, United States

Location

Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Foot and Ankle Specialists of the Mid Atlantic

Frederick, Maryland, 21703, United States

Location

Wound Care Experts

Las Vegas, Nevada, 89148, United States

Location

Lower Extremity Institute for Research and Therapy

Youngstown, Ohio, 44512, United States

Location

Wound Centrics

Corpus Christi, Texas, 78404, United States

Location

PULSE: Amputation Prevention Center, LLC

El Paso, Texas, 79902, United States

Location

Foot and Ankle Specialists of the Mid Atlantic

Salem, Virginia, 24153, United States

Location

United Wound Healing P.S

Auburn, Washington, 98092, United States

Location

Related Publications (1)

• Armstrong DG, Orgill DP, Galiano RD, Lantis J, Glat PM, Gitterle M, Carter MJ, Young N, Zelen CM. A Borate-Based Bioactive Glass Advances Wound Healing in Non-Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial. Int Wound J. 2025 Oct;22(10):e70763. doi: 10.1111/iwj.70763.

  PMID: 41014175 RESULT

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Donald Buck, MD
• Organization: ETS Wound Care, LLC

dbuck@etswoundcare.com

410-490-5998

Study Officials

• David Armstrong, DPM, MD, PhD

  USC/Salsa

  STUDY CHAIR

• Charles M Zelen, DPM

  Professional Education and Research Institute

  PRINCIPAL INVESTIGATOR

• Robert Galiano, MD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: September 13, 2022
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Locations

US (15)