Additional Hyperbaric Oxygen After Lower Extremity Amputation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric oxygen therapy.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial
Overview
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 hyperbaric oxygen therapy, or control group.
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 to be re-amputated more proximally. In these patients oxygen levels are often the decisive factor. Providing additional oxygen under hyperbaric conditions will increase tissue oxygen concentration sufficient for the amputation stump to heal. This will give the patients a more distal amputation with better condition for ambulation.
Interventions
- Procedure Hyperbaric oxygen therapy
Breathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions
Primary outcome measures
- Intact skin with no abnormal openings at the site of primary amputation [Time frame: 12 weeks]
Secondary outcome measures (12)
- Intact skin with no abnormal openings at the site of amputation at 6 months [Time frame: 6 months]
- Intact skin with no abnormal openings at the site of amputation at 9 months [Time frame: 9 months]
- Intact skin with no abnormal openings at the site of amputation at 1 year [Time frame: 12 months]
- Time to closed and intact skin at the site of amputation [Time frame: 1 year]
- Reamputations [Time frame: 1 year]
- Number of wound revision [Time frame: 1 year]
- Days in hospital during follow up [Time frame: 1 year]
- Visual analog pain scale (VAS) [Time frame: baseline]
- Visual analog pain scale (VAS) [Time frame: 12 weeks]
- Visual analog pain scale (VAS) [Time frame: 6 months]
- Visual analog pain scale (VAS) [Time frame: 1 year]
- RAND 36-Item Short Form Health Survey [Time frame: baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 2 centers
- Diakonhjemmet Hospital — Oslo
- Orthopedic Center, Ullevål University Hopspital — Oslo
Identifiers
NCT: NCT03594344 · 2017/1587