The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks using a modified platform trial design.
At least 18 years of age or older.
Has a medical diagnosis of venous insufficiency with an open wound to the lower extremity.
At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
Target ulcers must be treated with compression therapy for at least 14 days prior to enrollment.
The potential subject must consent to using the prescribed compression therapy for the duration of the study.
The potential subject must agree to attend the weekly study visits required by the protocol.
The potential subject must be willing and able to participate in the informed consent process.
Parallel
Standard of Care (SOC)
Other interventionBeginning at the screening visit, participants will receive weekly treatment of standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first
Corplex P
DeviceParticipants will receive weekly applications of Corplex P/Allacor P/Theracor P and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
Theracor
DeviceParticipants will receive weekly applications of Theracor and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
The percentage of target ulcers achieving complete wound closure
Determine the percent of target ulcers achieving complete wound closure at 12 weeks. In addition, a qualified third-party clinician will independently confirm wound closure.
Adverse events
Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).
Time to closure for the target ulcer
Time to closure will be determined for each treatment group and compared to SOC
Percent area reduction
Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to Treatment Visit (TV)-13
Change in pain in target ulcer
Change in target ulcer pain assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10 where higher score indicates more severe pain and pain-related interference with life and activities) at TV-1, TV-4, TV-7, TV-10, and TV-13.
Determine improvement in Quality of Life - wQOL
Quality of Life assessed using the Wound Quality of Life (wQOL) checklist at TV-1, TV- 4, TV-7, TV- 10, and TV-13.
This trial is not recruiting at the moment. You can still explore other options:
