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?
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
The intervention to be applied is an advanced wound care matrix composed of human keratin to be applied at two different treatment frequencies.
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
Wound Closure
The proportion of subjects that achieve complete closure of the target wound with each treatment.
Time frame: 12 weeks
Time to Wound Closure
The time required for target ulcers to achieve complete closure with each treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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").
Time frame: From date of first screening until date of documented wound closure or study conclusion, whichever comes first, assessed up to 15 weeks
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