Clinical trial Recruiting at 2 sites Interventional Ages 18 to 90

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 typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment120 (estimated)
SponsorOslo University Hospital
Academic / other
Locations2 sites (Oslo and 1 other locations)
StatusRecruiting
StartedJuly 4, 2018
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedMarch 30, 2025
Trial IDNCT03594344 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.