Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care i… (NCT04927702) | Clinical Trial Compass
TerminatedNot Applicable
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
Stopped: Study was terminated due to slow enrollment
United States48 participantsStarted 2021-07-19
Plain-language summary
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participant is at least 18 years old
✓. Participant is willing and capable of complying with all protocol requirements
✓. Participant or legally authorized representative (LAR) is willing to provide written informed consent
✓. Participant has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
✓. Ulcer(s) must be located at least in part on the foot or ankle
✓. Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy
✓. Wound size must be \>1.0 cm\^2 and \< 25 cm\^2 on the day of randomization and initial application of the study product, after initial debridement
✓. Participant has adequate circulation to the affected extremity(ies), as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
Exclusion criteria
What they're measuring
1
For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound
Timeframe: 12 weeks
2
For Venous Leg Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound
. Participant has been previously enrolled into this study, or is currently participating in another prospective drug or device study that has not reached its primary endpoint
✕. Participant is pregnant, breast feeding or planning to become pregnant
✕. Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
✕. Participant has a life expectancy less than six months as assessed by the investigator
✕. Participant has received skin substitutes during the screening period or within 14 days prior to beginning of screening period
✕. Participant has an additional wound within 3 cm of the study wound(s) or study wounds are less than 3 cm apart
✕. Hgb A1c \> 12 percent within 3 months prior to randomization
✕. Participant not in reasonable metabolic control in the judgment of the investigator