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Additional Hyperbaric Oxygen After Lower Extremity Amputation

Additional Hyperbaric Oxygen After Lower Extremity Amputation

Recruiting
18-90 years
All
Phase N/A

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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.

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.

Eligibility

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

Study details
    Diabetes Mellitus
    Claudication
    Intermittent
    Critical Limb Ischemia
    Osteomyelitis
    Amputation
    Lower Extremity Ulcer
    Diabetic Angiopathy
    Diabetic Neuropathies
    Diabetic Foot

NCT03594344

Oslo University Hospital

27 January 2024

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