Status:
TERMINATED
Hyperbaric Oxygen and Outcome After Below Knee Amputations
Lead Sponsor:
Duke University
Conditions:
Amputation; Postoperative, Sequelae
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 postopera...
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 vascula...
Eligibility Criteria
Inclusion
- Able to consent
- Non-traumatic indication for lower limb amputation
- Able to receive hyperbaric oxygen therapy
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04717557
Start Date
January 1 2021
End Date
October 31 2023
Last Update
August 11 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710