A Multi-center, Randomized, Parallel, Crossover Design Study of Non-healing Diabetic Foot Ulcers, Treated With Cryopreserved, Umbilical Cord Allograft (NEOX® CORD 1K) Versus Standard of Care That Are Followed for 12 Weeks (CONDUCT I)

NCT02166294 NA TERMINATED

In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K will be evaluated in patients suffering from non-healing diabetic foot ulcers. NEOX® CORD 1K is a cryopreserved human Amniotic Membrane and Umbilical Cord (AM/UC) matrix intended for use as a wound covering for dermal ulcers and defects. It is designated as a Human Cell \& Tissue Product (HCT/P) by the U.S. FDA.

Details

Lead sponsor	Amniox Medical, Inc.
Phase	NA
Status	TERMINATED
Enrolment	18
Start date	2014-06
Completion	2015-06

Conditions

• Foot Ulcer, Diabetic

Interventions

• NEOX® CORD 1K
• Standard of Care (Pressure Bandage)

Primary outcomes

• Complete wound closure — 12 weeks
  Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator
• Number of participants with adverse events — 12 weeks
  Number of participants with adverse events will be compared between the two groups.

Countries

United States