Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
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|ClinicalTrials.gov Identifier: NCT03626623|
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : December 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetic Foot Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1||Device: Cytal Wound Matrix 1-Layer Other: Standard of Care (SOC)||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled Trial Comparing Cytal Wound Matrix 1-Layer to Standard of Care (SOC) in the Management of Diabetic Foot Ulcers (DFUs)|
|Actual Study Start Date :||May 21, 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||May 2022|
Placebo Comparator: Standard of Care (SOC)
The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds.
Other: Standard of Care (SOC)
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.
Active Comparator: Cytal Wound Matrix 1-Layer
The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU).
Device: Cytal Wound Matrix 1-Layer
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.
- Incidence of Wound Closure [ Time Frame: up to 12 weeks ]The primary endpoint of the study is to measure the incidence of complete wound closure (defined as 100% epithelialization) between randomized groups.
- Wound Size Change [ Time Frame: up to 12 weeks ]Measure changes in wound size, measured in cm2/week between randomized groups.
- Complete Wound Closure Time [ Time Frame: up to 12 weeks ]Measure time to complete wound closure between randomized groups.
- Wound Recurrence [ Time Frame: at 26 week visit and 52 week visit ]Measure wound recurrence after healing is complete between randomized groups.
- Short Form-20 (SF-20) [ Time Frame: Baseline visit, visit #7, visit #13, 26 wk. visit, and 52 wk.visit ]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.
- Diabetic Foot Ulcer Scale- Short Form (DFS-SF) [ Time Frame: Baseline visit, 26 week visit, and 52 week visit ]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.
- Visual Analogue Scale (VAS) for Pain [ Time Frame: Up to 52 week visit (until study completion) ]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.
- Katz Index of Independence in Activities of Daily Living (KATZ ADL) [ Time Frame: Baseline visit, visit 7, visit 13, 26 wk visit, and 52 wk visit ]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.
- Adverse Events Frequency [ Time Frame: up to 52 week visit (until study completion) ]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.
- Narcotic Prescription Changes Between Trial Arms [ Time Frame: up to 52 week visit (until study completion) ]This outcome measures changes in number of diabetic foot ulcer (DFU) related narcotic prescriptions by study participant and between randomized groups.
- Participant Ambulatory Status [ Time Frame: up to 52 week visit (until study completion) ]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.
- Return to Work Status [ Time Frame: up to 52 week visit (until study completion) ]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.
- Diabetic Foot Ulcer (DFU) Specific Ancillary Medical Care [ Time Frame: up to 52 week visit (until study completion) ]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.
- Diabetic Foot Ulcer (DFU) Related Direct Product(s) Costs [ Time Frame: up to 52 week visit (until study completion) ]This outcome measures direct costs of the products by total cost per subject stratified by healed vs. non healed DFU.
- Indirect Diabetic Foot Ulcer (DFU) Product(s) Costs [ Time Frame: up to 52 week visit (until study completion) ]This outcome measures total indirect and incidental costs of diabetic foot ulcer products used per study participant by each visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626623
|Contact: Tejal Gambhir, MPH||(443) email@example.com|
|Contact: Mike Anibaba||(443) 283-2798||Mikeanibaba@acell.com|
|United States, California|
|Limb Preservation Platform, Inc.||Recruiting|
|Fresno, California, United States, 93710|
|Contact: Vanessa Cazzell, Ph.D. 559-431-1700|
|Principal Investigator: Shawn Cazzell, DPM|
|United States, Louisiana|
|Louisiana State University Health Science Center (LSUHSC)||Recruiting|
|New Orleans, Louisiana, United States, 70112|
|Contact: Alison Fleury, RN 504-903-9000 firstname.lastname@example.org|
|Principal Investigator: John T. Paige, MD|
|Sub-Investigator: Jace Landry, MD|
|United States, Maryland|
|MedStar Health Research Institute||Not yet recruiting|
|Hyattsville, Maryland, United States, 20782|
|Contact: Melissa McLawhorne, RN 202-877-2064|
|Principal Investigator: Jeffery Shupp, MD|
|Study Chair:||Tejal Gambhir||ACell Inc.|