Hyperbaric Oxygen and Outcome After Below Knee Amputations

NCT04717557 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: Pro00093687
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation; Postoperative, Sequelae

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Mortality During the Inpatient Period

  During inpatient stay immediately after amputation, up to 13 days

• Number of Participants With Re-operation

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

  Up to 90 days after amputation

• Number of Participants With Wound Infection

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

  Up to 90 days after amputation

Secondary Outcomes (5)

• Hospital Length of Stay

  up to approximately 30 days

• Number of Participants With 90-day Mortality

  Up to 90 days after amputation

• Number of Participants With Complete Healing of Amputation Wound Healing at 4 Weeks Following Surgery

  4 weeks after amputation

• Number of Participants With Complete Healing of Amputation Wound Healing at 8 Weeks Following Surgery

  8 weeks after amputation

• Number of Participants Able to Ambulate With Prosthesis

  6 months after amputation

Other Outcomes (1)

• Number of Participants With Hospital Readmission

  Up to 90 days after amputation

Study Arms (2)

Hyperbaric Oxygen Plus Regular Care

EXPERIMENTAL

Hyperbaric oxygen (2 hours at 2 atmospheres absolute) to be administered 1-2 times daily for up to 10 treatments after amputation. Usual care for patients with amputation (dressing changes and treatment of infection) will be administered in parallel.

Drug: Hyperbaric Oxygen

Regular Care

NO INTERVENTION

Usual care for patients with amputation, including dressing changes and treatment of infection.

Interventions

Hyperbaric Oxygen DRUG

Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation

Also known as: HBO2

Hyperbaric Oxygen Plus Regular Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to consent
• Non-traumatic indication for lower limb amputation
• Able to receive hyperbaric oxygen therapy

You may not qualify if:

• Unable to consent
• Contraindication to hyperbaric oxygen
• End stage renal disease on dialysis
• Current renal failure as measured by creatinine levels vs baseline change of more than 1 mg/dL and for whom dialysis is expected to be required with the next month
• Calciphylaxis
• Traumatic injuries that are the cause of the amputation
• Cancer being treated by chemotherapy, scheduled to be treated, or being treated or scheduled to be treated by radiation.
• Limb amputation secondary to ischemic complications from other operations
• Second amputation or reoperation on prior amputation
• Pregnancy

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Limitations and Caveats

Due to insufficient recruitment the study was terminated.

Results Point of Contact

• Title: Dr. Richard Moon
• Organization: Duke University

richard.moon@duke.edu

919-684-8762

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Permuted block

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 22, 2021
• Study Start: January 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: October 31, 2023
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)