Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot

In brief

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.

Key facts

Study ID

NCT06403605

Run by

ETS Wound Care, LLC

People needed

148

Starts

2022-09-13

Expected to finish

2025-01-17

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
• 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.

You may not qualify if…

• 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.
• Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
• A potential subject with end stage renal disease requiring dialysis is excluded.
• A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.
• A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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