Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers

Completed · Not applicable

Conditions studied: Ulcer Healing, Diabetic Foot Ulcer

In brief

The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®. In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either weekly or bi-weekly to the target wound. Researchers will compare how weekly or bi-weekly application of ProgenaMatrix affects the healing of DFUs. The primary questions to be answered are: 1. How many patients achieve wound closure in 12 weeks with ProgenaMatrix treatment? And 2. What is the change in wound area during the trial in each group?

Key facts

Study ID

NCT05797285

Run by

ProgenaCare Global, LLC

People needed

26

Starts

2023-02-28

Expected to finish

2023-12-20

Last updated by the study team

2024-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 1 or 2 diabetes mellitus
• Target diabetic foot ulcer with a minimum surface area of 1.0 cm\^2 and a maximum surface area of 20.0 cm\^2 measured post-debridement with photographic planimetry.
• Target ulcer must have been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care prior to initial screening
• Target ulcer must be located on the foot with at least 50% of its area below the malleolus
• Target ulcer must be full thickness on the foot or ankle that does not probe to bone
• Adequate circulation in the affected foot documented within 3 months of initial screening visit, as determined by one of the following: transcutaneous oximetry measurement (TCOM) greater or equal to 30 mmHg, ankle-brachial index (ABI) between 0.7 and 1.3, biphasic pulse volume recording (PVR), toe-brachial index (TBI) greater than 0.6, or arterial Doppler ultrasound evaluating for biphasic dorsalis pedis and posterior tibial vessels at the ankle level
• If 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 on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization
• Subject must consent to using the prescribed off-loading method for the duration of the study
• Subject must agree to attend weekly study visits required by the protocol
• Subject must be willing and able to participate in the informed consent process

You may not qualify if…

• Subjects known to have a life expectancy of < 6 months
• Infection of the target ulcer or cellulitis in the surrounding skin
• Presence of osteomyelitis or exposed bone, or wounds that probe to bone or joint capsule on investigator's exam or radiographic evidence
• Infection in the target ulcer requiring systemic antibiotic therapy
• Subjects receiving immunosuppressants (including systemic corticosteroids > 10 mg Prednisone per day or equivalent) or cytotoxic chemotherapy
• Topical application of steroids to the ulcer surface within one month of initial screening
• Subjects with previous partial amputation on the affected foot that impedes proper offloading of the target ulcer
• Subjects with a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit
• Subjects with a serum creatinine level ≥ 3.0mg/dL within 6 months of randomization
• Surface area of the target ulcer reduces in size by more than 30% in the two weeks between the initial screening and randomization during which they are subject to standard of care
• Subjects with acute or inactive Charcot foot that impedes proper offloading of the target ulcer
• Women who are pregnant or considering becoming pregnant within the next 6 months
• Subjects with end stage renal disease requiring dialysis
• Subjects who participated in a clinical trial involving treatment with an investigational product within the previous 30 days
• Subjects who, in the opinion of the investigator, have a medical or psychological condition that may interfere with study assessments
• Subjects treated with hyperbaric oxygen therapy or a cellular and/or tissue product (CTP) in the 30 days prior to the initial screening visit

Where it is running

• Doctors Research Network — Miami, Florida, United States
• Foot and Ankle Specialists of the Mid-Atlantic (FASMA) — Frederick, Maryland, United States
• Foot and Ankle Specialists of the Mid-Atlantic (FASMA) — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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