This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention.
This is a prospective, two-armed, multi-center randomized controlled trial (RCT) comparing Cytal Wound Matrix 1-Layer intervention to standard of care (SOC) intervention in patients presenting with diabetic foot ulcers (DFU). Up to one hundred and fifty patients recruited from US based medical centers and randomized (using a 2(active):1(control) randomization scheme) to receive either Cytal Wound Matrix 1-Layer intervention or standard of care intervention.Complete wound closure incidence, wound healing rates, wound recurrence, and various health related quality of life (HRQOL) outcomes will be compared between study arms. Additionally, a cost effective analysis (i.e. direct and indirect costs) and review of individual and group changes in narcotic prescription patterns will also be evaluated. While incidence of wound closure rates will be evaluated through 12 weeks, protocol defined patient follow-up is for two years. Data will be captured for remaining study objectives during these two years. An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee (CEC) will adjudicate all adverse events (AEs) and serious adverse events (SAEs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use.
Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings.
Limb Preservation Platform, Inc.
Fresno, California, United States
Louisiana State University Health Science Center (LSUHSC)
New Orleans, Louisiana, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Number of Wounds With Wound Closure
The primary endpoint of the study is to measure the incidence of complete wound closure (defined as 100% epithelialization) between randomized groups. Number of wounds was calculated as the total across all participants.
Time frame: up to 12 weeks
Wound Size Change
Measure changes in wound size, measured in cm2/week between randomized groups.
Time frame: up to 12 weeks
Complete Wound Closure Time
Measure time to complete wound closure between randomized groups.
Time frame: up to 12 weeks
Wound Recurrence
Measure wound recurrence after healing is complete between randomized groups.
Time frame: at 26 week visit and 52 week visit
Short Form-20 (SF-20)
The Short Form-20 is a 20-item questionnaire used to assess generic health outcomes from the participant's perspective. Scores are linearly measured from 0 (worst) to 100 (best) health functioning scores, respectively.
Time frame: Baseline visit, visit #7, visit #13, 26 wk. visit, and 52 wk.visit
Diabetic Foot Ulcer Scale- Short Form (DFS-SF)
The diabetic foot ulcer scale- short form (DFS-SF) is a 29-item questionnaire designed to assess the impact of diabetic foot ulcers (DFUs) and their intervention on quality of life of participants diagnosed with diabetes. Scores measured from 0 (lower) to 100 (higher) quality of life, respectively.
Time frame: Baseline visit, 26 week visit, and 52 week visit
Visual Analogue Scale (VAS) for Pain
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The visual analogue scale (VAS) is a psychometric response scale for pain. It measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a vertical line on a 10 cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in cm with a higher score (100) indicating greater pain intensity.
Time frame: Up to 52 week visit (until study completion)
Katz Index of Independence in Activities of Daily Living (KATZ ADL)
The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e. dependence) or one (i.e. independence). This will be completed with the aid of a trained study staff member.
Time frame: Baseline visit, visit 7, visit 13, 26 wk visit, and 52 wk visit
Adverse Events Frequency
This outcome measures diabetic foot ulcer (DFU) related adverse event frequency including unexpected adverse device events (UADEs) or serious adverse experiences (SAEs) throughout the duration of the study as well as evaluate such adverse event frequencies between randomized groups.
Time frame: up to 52 week visit (until study completion)
Narcotic Prescription Changes Between Trial Arms
This outcome measures changes in number of diabetic foot ulcer (DFU) related narcotic prescriptions by study participant and between randomized groups.
Time frame: up to 52 week visit (until study completion)
Participant Ambulatory Status
This outcome measures any changes in ambulatory status (i.e. bed, wheel chair, walk w/ assistance, or walk independent) by study participant and between randomized groups.
Time frame: up to 52 week visit (until study completion)
Return to Work Status
This outcome measures differences in "return to work status" and/or "reported work status", activities of daily living, or disability status by study participant and between randomized groups.
Time frame: up to 52 week visit (until study completion)
Diabetic Foot Ulcer (DFU) Specific Ancillary Medical Care
This outcome measures the incidence of diabetic foot ulcer (DFU) specific related medical care a study participant receives outside of the medical care provided by the investigator. Examples of ancillary care include, but are not limited to, emergency room (ER) visits, urgent care visits, outside medical procedures such as surgery, etc. The incidence of subjects requiring ancillary medical care will be tabulated and compared between randomized groups. This data will be collected via two questions (i.e. "Did participant receive any ancillary medical care?" and "If "yes", then specify where"). Responses are verified using source documentation.
Time frame: up to 52 week visit (until study completion)
Diabetic Foot Ulcer (DFU) Related Direct Product(s) Costs
This outcome measures direct costs of the products by total cost per subject stratified by healed vs. non healed DFU.
Time frame: up to 52 week visit (until study completion)
Indirect Diabetic Foot Ulcer (DFU) Product(s) Costs
This outcome measures total indirect and incidental costs of diabetic foot ulcer products used per study participant by each visit.
Time frame: up to 52 week visit (until study completion)