Actively Recruiting
Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial
Led by Oslo University Hospital · Updated on 2025-03-30
120
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
D
Diakonhjemmet Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of adding hyperbaric oxygen therapy after lower extremity amputation. The study focuses on patients who have had amputations due to chronic wounds, osteomyelitis, ischemia, or necrosis, conditions commonly associated with poor healing. Hyperbaric oxygen therapy has been used for decades to help heal difficult wounds by increasing oxygen levels in tissues, potentially improving healing at the amputation site and reducing the need for further amputations. Participants who have undergone lower extremity amputation will be randomly assigned to one of two groups. One group will receive 30 sessions of hyperbaric oxygen therapy, each lasting 90 minutes at 2.4 atmosphere absolute (ATA) with 100% oxygen. The first treatment must begin within seven days after amputation, and the therapy is provided as outpatient care after hospital discharge. The other group will receive standard care and outpatient follow-up without hyperbaric oxygen therapy. During the study, participants will be monitored for skin healing at the amputation site up to 12 months, including assessments at 12 weeks, 6 months, 9 months, and 1 year. Researchers will measure outcomes like intact skin without abnormal openings, time to wound closure, reamputations, wound revisions, hospital days, pain levels, quality of life, mobility, and foot and ankle function. Follow-up visits and evaluations will occur regularly to track healing progress and overall health after treatment.
CONDITIONS
Brief Title
Additional Hyperbaric Oxygen After Lower Extremity Amputation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lower extremity amputation due to chronic wound, osteomyelitis, ischemia, or necrosis
- Fit to receive hyperbaric oxygen therapy as determined by an anesthesiologist or hyperbaric medicine physician
- Able to cooperate with and attend follow-up appointments
- Included within 7 days after the final surgery
You will not qualify if you...
- Not meeting the inclusion criteria
- Pregnancy
- Dementia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until completion of 30 sessions
Participants receive 30 sessions of hyperbaric oxygen therapy, each session lasting 90 minutes at 2.4 ATA with 100% oxygen. Treatment starts within 7 days after amputation and is given as outpatient treatment after hospital discharge.
30 outpatient visits
Duration - Up to 1 year after treatment
Participants are followed for up to 1 year after treatment to monitor wound healing, pain levels, quality of life, and need for reamputation.
Multiple follow-up visits at 12 weeks, 6 months, 9 months, and 1 year
Trial Site Locations
Total: 2 locations
1
Diakonhjemmet Hospital
Oslo, Norway, 0319
Actively Recruiting
2
Orthopedic Center, Ullevål University Hopspital
Oslo, Norway, 0407
Actively Recruiting
Research Team
J
Jonas Rydinge, MD
E
Elisabeth I Ellingsen Husebye, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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