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Organogenesis NuShield RCT
||A Prospective, Multicenter, Randomized, Controlled Clinical Study of NuShiled and Standard of Card (SOC) Compared to SOC Alone for the Management of Diabetic Foot Ulcers
Diabetic Foot Ulcers
||Mark Iafrati, MD
This study will follow a superiority design that will test whether the treatment group (NuShield plus SOC) compared to the control group (SOC alone) demonstrates statistically significant differences for time to and frequency of complete wound closure in patients with diabetic foot ulcers. Subjects in the study will be randomized 1:1 to either: Group 1, NuShield plus SOC weekly for up to 24 weeks, or Group 2, SOC (control) weekly for up to 24 weeks.
- Subjects with diabetic foot ulcers which extend into the papillary (shallow) dermis, or into the reticular (deep) dermis, or into the subcutaneous fat, but not extending into muscle, tendon, capsule, or bone.
- Subjects with controlled Diabetes (HbA1c <= 10% within 4 weeks prior to initial screening visit)
- Index ulcer has been present for greater than 4 weeks prior to the initial screening visit.
- Treatment with wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 30 days of the screening visit and throughout the study.
- History of bone cancer or metastatic disease of the affected limb or chemotherapy within the 12 months prior to randomization.
- History of radiation at the ulcer site.
Subjects have 12 weekly visits, if subject is randomized to SOC alone and ulcer is not closed in 12 weeks they have the option to cross over to NuShield treatment for up to an additional 12 weeks. Should ulcer heal early in the study, the subject shall return 2 weeks post for the confirmation of healing visit. Weekly study visit requirements will include quality of life questionnaire, ulcer photographs, ulcer management, and NuShield application (for patients randomized to NuShield plus SOC).