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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 is a Phase 1 study that was terminated before completion, run by Duke University. The registered enrollment target is 4 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04717557
The ClinicalTrials.gov registry entry for NCT04717557 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hyperbaric Oxygen is the first listed.
NCT04717557 reports 0 study locations.
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.
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