NCT04717557

Hyperbaric Oxygen and Outcome After Below Knee Amputations

Terminated Phase 1, PHASE2 Results posted Last updated 11 August 2025

What this trial tests

Phase 1, PHASE2 trial testing Hyperbaric Oxygen in Amputation; Postoperative, Sequelae in 4 participants. Terminated before completion.

Timeline

1 January 2021

Primary endpoint
31 July 2023

31 October 2023

Quick facts

Lead sponsor	Duke University
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	4
Start date	1 January 2021
Primary completion	31 July 2023
Estimated completion	31 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Hyperbaric Oxygen — full drug profile →

Conditions studied

• Amputation; Postoperative, Sequelae — all drugs for Amputation; Postoperative, Sequelae →

Sponsor

Duke University

Who can join

18 and older, any sex, with Amputation; Postoperative, Sequelae. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Mortality During the Inpatient Period Primary · During inpatient stay immediately after amputation, up to 13 days

Group	Value	95% CI
Hyperbaric Oxygen Plus Regular Care	1
Regular Care	0

Number of Participants With Re-operation Primary · Up to 90 days after amputation

Unplanned return to the OR (operating room) for a surgical procedure

Group	Value	95% CI
Hyperbaric Oxygen Plus Regular Care	0
Regular Care	0

Number of Participants With Wound Infection Primary · Up to 90 days after amputation

Any wound site infection that was culture positive or required antibiotic treatment

Group	Value	95% CI
Hyperbaric Oxygen Plus Regular Care	0
Regular Care	0

Hospital Length of Stay Secondary · up to approximately 30 days

Hospital length of stay immediately after amputation

Group	Value	95% CI
Hyperbaric Oxygen Plus Regular Care	5.3	4 – 7
Regular Care	13	13 – 13

Number of Participants With 90-day Mortality Secondary · Up to 90 days after amputation

Death within 90 days after amputation

Group	Value	95% CI
Hyperbaric Oxygen Plus Regular Care	1
Regular Care	0

Number of Participants With Complete Healing of Amputation Wound Healing at 4 Weeks Following Surgery Secondary · 4 weeks after amputation

Complete wound healing at 4 weeks after amputation

Group	Value	95% CI
Hyperbaric Oxygen Plus Regular Care	0
Regular Care	0

Number of Participants With Complete Healing of Amputation Wound Healing at 8 Weeks Following Surgery Secondary · 8 weeks after amputation

Complete wound healing at 8 weeks after amputation

Group	Value	95% CI
Hyperbaric Oxygen Plus Regular Care	1
Regular Care	0

Number of Participants Able to Ambulate With Prosthesis Secondary · 6 months after amputation

Ability to ambulate with a prosthesis at 6 months post amputation

Group	Value	95% CI
Hyperbaric Oxygen Plus Regular Care	2
Regular Care	0

Number of Participants With Hospital Readmission Secondary · Up to 90 days after amputation

Any readmission to hospital after initial discharge

Group	Value	95% CI
Hyperbaric Oxygen Plus Regular Care	0
Regular Care	1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.