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)
Organogenesis
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects must be at least 18 years of age or older. 2. 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) 3. The index ulcer must have been present for a minimum of 4 weeks 4. The subject must have a study wound that falls within a specified size range 5. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the incl…
Interventions
- OtherNuShield®
NuShield® is a dehydrated placental allograft
Location
- Cutting Edge ResearchPickerington, Ohio