Status:
RECRUITING
Additional Hyperbaric Oxygen After Lower Extremity Amputation
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Diakonhjemmet Hospital
Conditions:
Diabetes Mellitus
Claudication, Intermittent
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperba...
Detailed Description
Hyperbaric oxygen therapy has been used to treat hard to heal wounds for decades. Amputation, especially distal lower extremity amputations have the same problem with healing and patients often need t...
Eligibility 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
Key Trial Info
Start Date :
July 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03594344
Start Date
July 4 2018
End Date
December 31 2026
Last Update
March 30 2025
Active Locations (2)
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1
Diakonhjemmet Hospital
Oslo, Norway, 0319
2
Orthopedic Center, Ullevål University Hopspital
Oslo, Norway, 0407