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

NCT02166294 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-06-27

No results posted yet for this study

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.

Conditions

  • Foot Ulcer, Diabetic

Interventions

OTHER

NEOX® CORD 1K

Amniotic Membrane Tissue is fetal membrane tissue that comprises the innermost layer of the human placenta, and the outermost lining of the umbilical cord. In addition to amniotic membrane, the umbilical cord also contains Wharton's jelly, a rich source of proteoglycans and growth factors. These tissues share the same cell origin as the fetus and serve to protect the fetus during development. This product does not contain live cells.

PROCEDURE

Standard of Care (Pressure Bandage)

Standard of Care wound, pressure dressing applied as needed at each visit.

Sponsors & Collaborators

  • Amniox Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles I. Romano · Amniox Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02166294 on ClinicalTrials.gov