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NCT02166294 · ClinicalTrials.gov registry record · NA
NEOX® CORD 1K vs Standard of Care in Non-healing Diabetic Foot Ulcers
A NA study, sponsored by Amniox Medical.
- Terminated
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT02166294: Clinical Trial NA study, sponsored by Amniox Medical.
NCT02166294 is a NA study that was terminated before completion, run by Amniox Medical. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02166294, a NA study, was terminated before completion, sponsored by Amniox Medical.
- TERMINATED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
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.
Primary Outcome
Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator
Interventions
- OTHER NEOX® CORD 1K
- PROCEDURE Standard of Care (Pressure Bandage)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-06 |
| Phase | NA |
Why NCT02166294 stopped before completion
NCT02166294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which NEOX® CORD 1K is the first listed.
NCT02166294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02166294 about?
NCT02166294 is a clinical study titled "NEOX® CORD 1K vs Standard of Care in Non-healing Diabetic Foot Ulcers". 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 ...
What is the current status of trial NCT02166294?
This trial is currently terminated. It is a NA study. The enrollment target is 18 participants. The study started on 2014-06. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02166294?
The interventions under investigation include: NEOX® CORD 1K (OTHER), Standard of Care (Pressure Bandage) (PROCEDURE).
Who is sponsoring clinical trial NCT02166294?
This trial is sponsored by Amniox Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02166294's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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