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NCT04717557 · ClinicalTrials.gov registry record · Phase 1
Hyperbaric Oxygen and Outcome After Below Knee Amputations
A Phase 1 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT04717557: Clinical Trial Phase 1 study, sponsored by Duke University.
NCT04717557 is a Phase 1 study that was terminated before completion, run by Duke University. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04717557, a Phase 1 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications. It is hypothesized that HBO2 given in the immediate postoperative period will reduce postoperative complications in patients undergoing below-the-knee amputations. The objective of this study will be to compare treatment and standard care groups, randomly created of eligible patients, to compare their postoperative complications and to assess their postoperative hospital length of stay, 90-day mortality, failure to heal at 4 and 8 week follow-up visits and ability to ambulate with a prosthesis at 6 months post amputation.
Interventions
- DRUG Hyperbaric Oxygen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2023-10-31 |
| Phase | Phase 1 |
Why NCT04717557 stopped before completion
NCT04717557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Hyperbaric Oxygen is the first listed.
NCT04717557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04717557 about?
NCT04717557 is a clinical study titled "Hyperbaric Oxygen and Outcome After Below Knee Amputations". This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications. It is hypothesized that HBO2 given in the immediate postoperative period will reduce postoperative complications in patients undergoing below-the-knee amputation...
What is the current status of trial NCT04717557?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2021-01-01. Estimated completion is 2023-10-31.
What interventions are being tested in trial NCT04717557?
The interventions under investigation include: Hyperbaric Oxygen (DRUG).
Who is sponsoring clinical trial NCT04717557?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04717557's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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