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

A Randomized Clinical Pilot Evaluating The Efficacy For Two Application Regimens Of A Unique Keratin Based Graft In The Treatment Of Non-Healing Diabetic Foot Ulcers

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?

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer; Ulcer Healing
• Intervention / Treatment: Device: human keratin graft

Detailed Description

ProgenaMatrix® is a human keratin graft that is 510K approved for application on diabetic foot wounds and has been shown in case studies and clinical practice to assist in wound healing . Additionally, a study published by Tang and Kirsner showed that keratin stimulates human keratinocyte migration and types IV and VII collagen expression. Therefore, based on this early promising data, a larger pilot is necessary to further validate these results and identify the likelihood of wound healing with weekly versus bi-weekly application. For consistency, one type of wound will be studied in this trial and DFU's have been chosen as they are some of the most common wounds seen in the wound clinics.

The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared synthetic, absorbable skin substitute matrix. The commercially available product is ProgenaMatrix® Advanced Wound Graft and consists of Human Keratin Matrix. In this trial, two groups of subjects with diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. 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).

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Doctors Research Network
  • Maryland
    • Frederick, Maryland, United States, 21703
      • Foot and Ankle Specialists of the Mid-Atlantic (FASMA)
  • Virginia
    • Salem, Virginia, United States, 24153
      • Foot and Ankle Specialists of the Mid-Atlantic (FASMA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weekly Human Keratin Graft Application; 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; The intervention to be applied is an advanced wound care matrix composed of human keratin to be applied at two different treatment frequencies.; Other Names: ProgenaMatrix
Experimental: Bi-Weekly Human Keratin Graft Application; 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; The intervention to be applied is an advanced wound care matrix composed of human keratin to be applied at two different treatment frequencies.; Other Names: ProgenaMatrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Closure	The proportion of subjects that achieve complete closure of the target wound with each treatment.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Wound Closure	The time required for target ulcers to achieve complete closure with each treatment.	From date of randomization until date of documented wound closure, assessed up to 12 weeks
Wound Area Change	The change in target wound area between treatment visits.	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	Changes in peripheral neuropathy of the foot with the target ulcer between treatment visits, assessed by the standard 10-point Semmes-Weinstein monofilament exam.	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	Changes in pain in the target ulcer assessed by the numerical pain rating scale from 0 (no pain) to 10 (worst pain possible).	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	Changes in patient quality of life relating to their wound using the wound quality of life assessment with 17 questions answered on a scale of 0 ("not at all") to 4 ("very much").	From date of first screening until date of documented wound closure or study conclusion, whichever comes first, assessed up to 15 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Cellulitis and Infection	Difference in number of participants presenting with cellulitis and/or infection in or around the target ulcer between treatment groups.	12 weeks
Number of Adverse Events Observed	The number and type of adverse events observed during the study.	15 weeks

Collaborators and Investigators

• Sponsor: ProgenaCare Global, LLC
• Collaborators: Professional Education and Research Institute
• Investigators: Study Chair: David G Armstrong, DPM,MD,PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcer; Wound Care
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: PRG-PM-DFU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes