Using hyperbaric oxygen therapy after lower limb amputation
Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 2 sites (Oslo and 1 other locations) |
| Trial ID | NCT03594344 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant or have dementia will not benefit from this study.
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 performed: Previous studies have shown promising results with hyperbaric oxygen therapy for wound healing, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Oslo and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.