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A Multi-center, Randomized, Controlled Study of Non-healing Diabetic Foot Ulcers (DFU) Treated With Standard of Care With or Without Cryopreserved Umbilical Cord Allograft (NEOX®CORD 1K)
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.
Details
| Lead sponsor | BioTissue Holdings, Inc |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 124 |
| Start date | 2016-02 |
| Completion | 2018-10-09 |
Conditions
- Diabetic Foot Ulcers
Interventions
- NEOX®CORD 1K
- standard of care
Primary outcomes
- Incidence of adverse events collected throughout the trial compared between the two groups — 16 weeks
Countries
United States, Canada