Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

NCT ID: NCT06403605

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-13
• Study Completion Date: 2025-01-17

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.

Detailed Description

This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.

There are two arms in the study:

Arm 1: SOC therapy (offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with resorbable bioactive glass fiber, MIRRAGEN™ Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

ARM 2: SOC therapy (offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with calcium alginate Fibracol dressing follwed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

Conditions

Diabetic Foot Ulcer; Ulcer Foot; Diabetic Foot

Keywords

DFU; Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOC primary dressing with MIRRAGEN™

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 Type: EXPERIMENTAL

Mirragen Advanced Wound Matrix

Intervention Type: 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 FIBRACOL™

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.

Group Type: ACTIVE_COMPARATOR

Fibracol

Intervention Type: 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.

Interventions

Mirragen Advanced Wound Matrix

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.

Intervention Type: DEVICE

Fibracol

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects must be at least 18 years of age or older.

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

3. 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.

4. 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.

5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.

6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone.

7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:

1. TCOM ≥30 mmHg

2. ABI between 0.7 and 1.3

3. PVR: Biphasic

4. TBI ˃0.6

5. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle

Exclusion Criteria

9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.

10. The subject must consent to using the prescribed off-loading method for the duration of the study.

11. The subject must agree to attend the weekly study visits required by the protocol.

12. The subject must be willing and able to participate in the informed consent process.

1. A subject known to have a life expectancy of < 6 months is excluded.

2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.

3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.

4. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.

5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.

6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.

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

8. 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.

9. If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.

10. 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.

11. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.

12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.

13. A potential subject with end stage renal disease requiring dialysis is excluded.

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

15. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.

16. A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Professional Education and Research Institute

OTHER

Sponsor Role: collaborator

ETS Wound Care, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Armstrong, DPM, MD, PhD

Role: STUDY_CHAIR

USC/Salsa

Charles M Zelen, DPM

Role: PRINCIPAL_INVESTIGATOR

Professional Education and Research Institute

Robert Galiano, MD

Role: STUDY_CHAIR

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

Locations

LA Foot and Ankle

Los Angeles, California, United States

Casa Colina

Pomona, California, United States

Center for Clincal Research

San Francisco, California, United States

Southernmost Foot and Ankle Specialists

Homestead, Florida, United States

Doctor's Research Network

South Miami, Florida, United States

Gateway Clinical Trials

O'Fallon, Illinois, United States

Foot and Ankle Center of Illinois

Springfield, Illinois, United States

Mercy Medical Center

Cedar Rapids, Iowa, United States

Foot and Ankle Specialists of the Mid Atlantic

Frederick, Maryland, United States

Wound Care Experts

Las Vegas, Nevada, United States

Lower Extremity Institute for Research and Therapy

Youngstown, Ohio, United States

Wound Centrics

Corpus Christi, Texas, United States

PULSE: Amputation Prevention Center, LLC

El Paso, Texas, United States

Foot and Ankle Specialists of the Mid Atlantic

Salem, Virginia, United States

United Wound Healing P.S

Auburn, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 41014175 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ETS-MG-DFU-02

Identifier Type: -

Identifier Source: org_study_id