A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs). The study is a prospective, multi-center, open label, RCT designed to collect subject outcome data on NuShield plus Standard of Care vs Standard of Care alone for the management of VLUs.
Subjects must be at least 18 years of age or older.
Index Ulcer must be of venous origin, as determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test)
The index ulcer must have been present for a minimum of 4 weeks
The subject must have a study wound that falls within a specified size range
Index ulcer is located on the leg, below the knee and at or above the malleoli.
Partial or full-thickness index ulcer extending into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.
The subject must be willing and able to participate, understand, and sign the IRB approved informed consent process prior to any study procedures.
Subjects agree to be compliant with all study requirements, including weekly study visits.
Parallel
NuShield®
Other interventionNuShield® is a dehydrated placental allograft
The proportion of subjects that obtain complete closure
The proportion of subjects that obtain complete closure. Complete closure is defined as full epithelialization of the wound with the absence of drainage and infection as well as visible epithelium on the wound surface.
The proportion of subjects that obtain complete closure on or before 12 weeks of treatment
The proportion of subjects that obtain complete closure on or before 12 weeks of treatment. Complete closure is defined as full epithelialization of the wound with the absence of drainage and infection as well as visible epithelium on the wound surface
Time to achieve complete wound closure of the index ulcer
Number of weeks to achieve complete wound closure
Percentage wound area reduction
Percentage change from baseline wound area to final wound area
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Organogenesis
Lead sponsor
Professional Education and Research Institute
Collaborator
