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

NCT05797285 | Completed FDA Device

• 1 other identifier: PRG-PM-DFU-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.How many patients achieve wound closure in 12 weeks with ProgenaMatrix treatment? And
2. 2.What is the change in wound area during the trial in each group?

Conditions

Ulcer Healing; Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer; Wound Care

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  The proportion of subjects that achieve complete closure of the target wound with each treatment.

  12 weeks

Secondary Outcomes (5)

• Time to Wound Closure

  From date of randomization until date of documented wound closure, assessed up to 12 weeks

• Wound Area Change

  From date of randomization until date of documented wound closure or study conclusion, whichever comes first, assessed up to 12 weeks

• Change in Peripheral Neuropathy

  From date of randomization until date of documented wound closure or study conclusion, whichever comes first, assessed up to 12 weeks

• Change in Wound Pain

  From date of randomization until date of documented wound closure or study conclusion, whichever comes first, assessed up to 12 weeks

• Change in Quality of Life

  From date of first screening until date of documented wound closure or study conclusion, whichever comes first, assessed up to 15 weeks

Other Outcomes (2)

• Presence of Cellulitis and Infection

  12 weeks

• Number of Adverse Events Observed

  15 weeks

Study Arms (2)

Weekly Human Keratin Graft Application

EXPERIMENTAL

Patients randomized into this arm will receive standard of care (offloading, debridement, and three-layer outer dressing) with the test material, the human keratin graft, reapplied weekly to the target wound.

Device: human keratin graft

Bi-Weekly Human Keratin Graft Application

EXPERIMENTAL

Patients randomized into this arm will receive standard of care (offloading, debridement, and three-layer outer dressing) with the test material, the human keratin graft, reapplied every other week to the target wound.

Device: human keratin graft

Interventions

human keratin graft DEVICE

The intervention to be applied is an advanced wound care matrix composed of human keratin to be applied at two different treatment frequencies.

Also known as: ProgenaMatrix

Bi-Weekly Human Keratin Graft Application; Weekly Human Keratin Graft Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ProgenaCare Global, LLC: lead
• Professional Education and Research Institute: collaborator

Study Sites (3)

Doctors Research Network

Miami, Florida, 33143, United States

Location

Foot and Ankle Specialists of the Mid-Atlantic (FASMA)

Frederick, Maryland, 21703, United States

Location

Foot and Ankle Specialists of the Mid-Atlantic (FASMA)

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• David G Armstrong, DPM,MD,PhD

  University of Southern California

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The treatments in this study will not be masked. Assessment of the primary study objective (wound closure) will be overseen by an adjudication panel of at least two wound care experts to reduce bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this trial, two groups of subjects with diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. The study has two phases: a 14-day screening phase to determine eligibility, and a 13-week treatment phase. Half of the patients will be randomized to a 510K FDA cleared ProgenaMatrix applied weekly and the other half will be randomized to a 510K FDA cleared ProgenaMatrix applied bi-weekly (i.e., once every two weeks). SOC includes offloading the DFU with controlled ankle movement (CAM) boots or total contact casting, appropriate sharp or surgical debridement, and wound care covering with ProgenaMatrix followed by a padded 3-layer dressing of 4x4 gauze, soft roll, and compressive wrap.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 4, 2023
• Study Start: February 28, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

US (3)