Hyperbaric Oxygen and Outcome After Below Knee Amputations

Hyperbaric Oxygen Therapy to Prevent Complications After Lower Limb Amputation

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.

Study Overview

• Status: Terminated
• Conditions: Amputation; Postoperative, Sequelae
• Intervention / Treatment: Drug: Hyperbaric Oxygen

Detailed Description

This is a clinical study to test the hypothesis that Hyperbaric Oxygen (HBO2) given in the immediate postoperative period for a total of 10 treatments after Below-the-Knee Amputation (BKA) for vascular disease will reduce postoperative complications. Patients scheduled for BKA at Duke University Medical Center will be reviewed for contraindications to HBO2. Patients for whom HBO2 is not contraindicated may choose to be enrolled in the study. Patients enrolled will be randomly assigned to receive treatment or standard postoperative care. Each patient receiving treatment will receive twice daily HBO2 for 2 hours at breathing 100% oxygen at 2 atmospheres absolute (ATA). Patients receiving HBO2 will breathe 100% oxygen via head tent while inside a hyperbaric chamber at Duke University Hospital. The statistical plan for this study will test non-directional hypotheses (two-sided tests). Bonferroni correction will be used to adjust for multiple tests. The main analysis of the primary efficacy hypotheses will include data from all randomized patients in the group to which random assignment is made. Hence, the analysis will be intention to treat. This study will primarily aim to assess whether patients receiving treatment suffer fewer complications, as defined by the Vascular Quality Initiative, vs. patients who receive standard care. The Vascular Quality Initiative (VQI) is a multicenter voluntary reporting system for outcomes related to vascular surgery. The primary outcome of this study, postoperative complications, will be those outcomes meeting the definition set out in the VQI data dictionary, the set of definitions for inclusion in the VQI database. This allows for a standard definition of complications recognized by a majority of US academic medical centers. Secondary outcomes include 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperbaric Oxygen Plus Regular Care; 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; Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation; Other Names: HBO2
No Intervention: Regular Care; Usual care for patients with amputation, including dressing changes and treatment of infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Hospital length of stay immediately after amputation	up to approximately 30 days
Number of Participants With 90-day Mortality	Death within 90 days after amputation	Up to 90 days after amputation
Number of Participants With Complete Healing of Amputation Wound Healing at 4 Weeks Following Surgery	Complete wound healing at 4 weeks after amputation	4 weeks after amputation
Number of Participants With Complete Healing of Amputation Wound Healing at 8 Weeks Following Surgery	Complete wound healing at 8 weeks after amputation	8 weeks after amputation
Number of Participants Able to Ambulate With Prosthesis	Ability to ambulate with a prosthesis at 6 months post amputation	6 months after amputation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Hospital Readmission	Any readmission to hospital after initial discharge	Up to 90 days after amputation

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro00093687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes