This site is intended for healthcare professionals
  • Home
  • /
  • Clinical trials
  • /
  • Uncategorised Disease
  • /
  • NuShield/Affinity for the Treatment of Neuropathic...
Clinical trial

NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers

Read time: 2 mins
Last updated:1st Mar 2015

"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
Study start date 2015-03-01

View full details