Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

NCT03398538 | Completed

• 1 other identifier: ETS-MG-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC dressings treatments for Diabetic Foot Wounds

Conditions

Diabetic Foot Ulcer; Ulcer Foot; Diabetic Foot

Keywords

DFU; Ulcer

Outcome Measures

Primary Outcomes (1)

• Percentage of index ulcers healed at 12 weeks

  examine percent of ulcers healed at week twelve

  12 weeks

Secondary Outcomes (7)

• Percentage of index ulcers healed at 6 weeks

  6 week

• Time to heal within 6 and 12 weeks

  6 and 12 weeks

• Percent Area Reduction (PAR) at 6 and 12 weeks

  6 and 12 weeks

• Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10"point discrimination test

  12 weeks

• Changes in wound quality of life, the " Wound Quality of Life Questionnaire" will be given to the clinical trial participants and administered during each visit

  12 weeks

Study Arms (2)

Mirragen Wound Matrix Dressing

EXPERIMENTAL

MIRRAGEN™ Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix dressing 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

Other: Offloading; Other: Additional (outer) Dressing Application; Other: Mirragen Wound Matrix Dressing

Fibracol Wound Dressing

ACTIVE COMPARATOR

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

Other: Offloading; Other: Additional (outer) Dressing Application; Other: Fibracol Wound Dressing

Interventions

Offloading OTHER

Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot

Also known as: Pressure relief

Fibracol Wound Dressing; Mirragen Wound Matrix Dressing

Additional (outer) Dressing Application OTHER

Application of outer a moisture retentive dressing, and a multi-layer compression dressing.

Also known as: Outer protective dressing

Fibracol Wound Dressing; Mirragen Wound Matrix Dressing

Mirragen Wound Matrix Dressing OTHER

Application of Mirragen to wound site along with standard of care treatment

Mirragen Wound Matrix Dressing

Fibracol Wound Dressing OTHER

Application of Fibracol Alginate along with standard of care treatment

Fibracol Wound Dressing

Eligibility Criteria

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

You may qualify if:

• At least 18 years old.
• Presence of a DFU, Wagner 1 (see Appendix B for definitions), extending at least through the dermis provided it is below the medial aspect of the malleolus.
• The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot they must be more than 2 cm distant from the index ulcer.
• Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1-year, as of the date the subject consents for study.
• Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
• Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a Toe Brachial Index (TBI) of \> 0.6 is acceptable.
• The target ulcer has been offloaded for at least 14 days prior to randomization.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits.

You may not qualify if:

• Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
• Subjects with a history of more than two weeks treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
• Subjects taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
• History of radiation at the ulcer site (regardless of time since last radiation treatment).
• Index ulcer has been previously treated or will need to be treated with any prohibited therapies. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
• Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
• Subject is pregnant or breast-feeding.
• Presence of diabetes with poor metabolic control as documented with an HbA1c \> 12.0 within 90 days of randomization.
• Subjects with end stage renal disease as evidenced by a serum creatinine ≥ 3.0 mg/dL within 6 months of randomization.
• Index ulcer has reduced in area by 20% or more after 14 days of SOC from SV1 to the TV1/randomization visit.

Sponsors & Collaborators

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

Study Sites (5)

Alan M Jacobs and Associates

St Louis, Missouri, 63117, United States

Location

Lower Extremity Institute of Research and Therapy

Youngstown, Ohio, 44512, United States

Location

Martinsville Research Institute

Martinsville, Virginia, 23116, United States

Location

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

Shenandoah Lower Extremity Research Institute

Troutville, Virginia, 24019, United States

Location

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

Study Officials

• David Armstrong, DPM, MD, PhD

  USC / Salsa

  PRINCIPAL INVESTIGATOR

• Charles M Zelen, DPM

  Professional Education and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 12, 2018
• Study Start: December 26, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

US (5)