NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers
"This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity compared to standard care alone.
Study Type: Interventional Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The NuTech NuShield Ande Affinity Membrane Product Evaluation for the Treatment Neuropathic Diabetic Ulcers (DFU)
Arms:
"Standard of Care
Wounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe."
"Experimental: NuShield
Wounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. In addition, wounds will be treated with a dehydrated amnion-chorion membrane, NuShield, for up to 4 weeks."
"Experimental: Affinity
Wounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. In addition, wounds will be treated with a fresh hypothermically stored amniotic membrane, Affinity, for up to 4 weeks."
Category | Value |
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Study start date | 2015-03-01 |