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NEOX® CORD 1K vs Standard of Care in Non-healing Diabetic Foot Ulcers — CONDUCT I  

Foot Ulcer, Diabetic Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

Patients identified for the study will have a non-healing diabetic ulcer, between 1-25cm² in size. The patient's wound(s) will be monitored for 2 weeks to document the wound pathology. Patients with less than 30% wound area reduction during the 2 week screening period and who meet all of the inclusion and none of the exclusion criteria, will be enrolled in the study. All patients will be assigned to a study or control group and undergo sharp debridement. NEOX® CORD 1K matrix will be applied to the treatment group on the day of debridement, covered with a wound veil, and standard dressing. Both groups will be monitored weekly, and the % decrease in wound size will be recorded at Baseline and Weeks 1, 2, 3, 4, 6, 8 and 12. If the wound is not progressing, additional application of NEOX® CORD 1K may be applied. The time to complete closure will be recorded for both groups. The study duration will be 12 weeks. Subjects in the control group that continue to suffer a non-healing wound at the week 12 visit will be offered an opportunity to cross-over to NEOX treatment and followed for an additional 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02166294
Study type Interventional
Source Amniox Medical, Inc.
Contact
Status Terminated
Phase N/A
Start date June 2014
Completion date June 2015
View Details
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