NCT02461641

NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers

The NuTech NuShield and Affinity Membrane Product Evaluation for the Treatment Neuropathic Diabetic Ulcers (DFU)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: NuTech Medical, Inc · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a three (3)-arm evaluation in 100 patients over 3 facilities with diabetic foot ulcers (DFU). Patients will be treated with NuShield or Affinity together with standard therapy or with standard care alone. For the purposes of this evaluation, standard therapy will consist of extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing, off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated. The patients will receive NuShield or Affinity plus standard therapy to determine optimal application method. The evaluation duration is 4 weeks with 8-week and 12-week follow-up visits. Patients with diabetic neuropathic foot ulcers of at least 4 weeks duration and free of clinical signs of infection at the time of treatment may be eligible for inclusion. At Week -1, each patient will undergo aggressive, surgical debridement. The site should be free of fibrin, necrotic and callous tissue. Digital imaging and planimetery of the target ulcer will be performed pre- and post initial debridement and at each subsequent visit as per the evaluation schedule. This evaluation is designed to investigate the potential of an allogeneic placental-derived amniotic membrane to accelerate healing of lower extremity DFU when used in conjunction with standard therapy. This potential will be measured as an increase in the rate of healing (daily decrease in percent wound area/volume compared to initial debrided ulcer area/volume) of patients treated with NuShield or Affinity plus standard wound care compared to patients treated with standard good wound care alone. Studies by Margolis and co-workers have demonstrated that the use of this surrogate marker, measured at 4 and 8 weeks of care, is predictive (\>70%) of wound healing in patients with DFU at the 20th week of care. \[Kantor 1998; Margolis 2003\] The secondary endpoint will be patients achieving complete closure (100%) by week 12.

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
OTHER	NuShield	NuShield is a sterilized dehydrated amnion chorion membrane patch.
OTHER	Affinity	Affinity is a aseptically produced hypothermically stored amniotic membrane patch.
OTHER	Standard of Care	Standard of Care for this study is defined as sharp debridement, moist wound dressing and offloading of the area using a DARCO shoe.

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-04-30
• Completion: 2018-10-25
• First posted: 2015-06-03
• Last updated: 2019-02-22

Locations

7 sites across 1 country: United States