NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers

NACompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

April 30, 2018

Study Completion Date

October 25, 2018

Conditions
Foot Ulcer, Diabetic
Interventions
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.

Trial Locations (7)

18512

Wound Institute and Research Center, Dunmore

19107

Temple University School of Pediatric Medicine, Philadelphia

46234

The Miller Care Group, Indianapolis

70570

The Wound Treatment Center, Opelousas

75224

Richard C. Galperin, DPM, FAPWCA, Dallas

78501

Futuro clinical Trials, LLC, McAllen

93720

Limb Preservation Platform, Fresno

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Organogenesis

INDUSTRY

lead

NuTech Medical, Inc

INDUSTRY

NCT02461641 - NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter