Plain-English translation of NCT03594344 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing hyperbaric oxygen therapy — a treatment where you breathe pure oxygen in a pressurized chamber — to help amputation wounds heal faster and more completely. After losing a lower leg or foot due to diabetes, poor circulation, or infection, some patients need to have a second amputation higher up the leg because the wound won't heal. This study aims to see if extra oxygen can give the first amputation site a better chance to heal, so patients might keep more of their leg.
When blood flow is poor or oxygen levels are low, amputation wounds often fail to heal properly, leading to a second, more severe amputation. Doctors have used this oxygen treatment for decades on other hard-to-heal wounds, but it hasn't been rigorously tested after amputation — so this trial will find out whether the treatment can truly make a difference.
You likely qualify if…
You likely don't qualify if…
If you join this trial, you'll either receive the standard wound care after surgery, or standard care plus 30 sessions of oxygen therapy (about 90 minutes each). The oxygen sessions happen as an outpatient, starting within a week after your amputation surgery. You'll also attend follow-up appointments at the clinic to check how your amputation is healing. The trial lasts several months as your surgical site recovers.
AI-generated summary from trial data · Jun 4, 2026 · Not medical advice
Norway
Sponsor
Oslo University Hospital
Collaborators
Diakonhjemmet Hospital
Enrollment target
~120 participants
Started
July 2018
Primary completion
December 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years – 90 Years
Last updated on clinicaltrials.gov in March 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Jonas Rydinge, MD
Ullevål University Hospital, orthopedic department
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.