Using hyperbaric oxygen therapy after lower limb amputation
Official title: Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial
Run by Oslo University Hospital · NCT03594344 · Data updated 2026-11-12
This study is testing if adding hyperbaric oxygen therapy after a leg amputation can help patients heal better and reduce the chances of needing more amputations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 2 sites (Oslo and 1 other locations) |
| Status | Recruiting |
| Started | July 4, 2018 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | March 30, 2025 |
| Trial ID | NCT03594344 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who have undergone lower extremity amputation due to chronic wounds, osteomyelitis, or ischemia and are fit for hyperbaric oxygen therapy.
✕Probably not a fit
Patients who are pregnant or have dementia will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of additional hyperbaric oxygen therapy on healing after lower extremity amputation. Patients will be randomly assigned to either receive hyperbaric oxygen therapy or be placed in a control group. The goal is to enhance tissue oxygen levels in the amputation stump, potentially leading to better healing outcomes and reducing the need for further amputations. The study focuses on patients with chronic wounds, osteomyelitis, and ischemia who have undergone amputation.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing rates and ambulation capabilities for patients after lower limb amputation.
How similar studies have gone: Previous studies have shown promising results with hyperbaric oxygen therapy for wound healing, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lower extremity amputation because of chronic wound, osteomyelitis, ischemia, necrosis. * Fit to receive hyperbaric oxygen therapy determined by an anesthesiologist/Hyperbaric Medicine Physician. * Able to cooperate and follow up appointments * Included within 7 days after final surgery Exclusion Criteria: * Not fulfilling inclusion criteria * Pregnancy * Dementia
Where it's running
-
Diakonhjemmet Hospital
Oslo, Norway Recruiting -
Orthopedic Center, Ullevål University Hopspital
Oslo, Norway Recruiting
Study contacts
- Principal investigator: Jonas V Rydinge, MD — Ullevål University Hospital, orthopedic department
- Study coordinator: Jonas Rydinge, MD
- Email: jonryd@ous-hf.no
- Phone: +4792291795
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.