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Non-healing Diabetic Foot Ulcers (DFU) Treated With SoC With or Without NEOX®CORD 1K

NCT02707406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-06-28

No results posted yet for this study

Summary

The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft.

The purpose of the study is to evaluate the safety, incidence and rate of wound closure following application of the product compared to standard of care in the treatment of difficult to heal diabetic foot ulcers.

Conditions

  • Diabetic Foot Ulcers

Interventions

OTHER

NEOX®CORD 1K

use of human tissue product wound covering

OTHER

standard of care

standard wound coverings

Sponsors & Collaborators

  • BioTissue Holdings, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-04-14
Completion
2018-10-09

Countries

  • United States
  • Canada

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 NCT02707406 on ClinicalTrials.gov