Additional Hyperbaric Oxygen After Lower Extremity Amputation

Last updated: March 25, 2025
Sponsor: Oslo University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Leg Ulcers

Diabetes And Hypertension

Diabetes Prevention

Treatment

Hyperbaric oxygen therapy

Clinical Study ID

NCT03594344
2017/1587
  • Ages 18-90
  • All Genders

Study 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 hyperbaric oxygen therapy, or control group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Lower extremity amputation because of chronic wound, osteomyelitis, ischemia,necrosis.

  • Fit to receive hyperbaric oxygen therapy determined by ananesthesiologist/Hyperbaric Medicine Physician.

  • Able to cooperate and follow up appointments

  • Included within 7 days after final surgery

Exclusion

Exclusion Criteria:

  • Not fulfilling inclusion criteria

  • Pregnancy

  • Dementia

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Hyperbaric oxygen therapy
Phase:
Study Start date:
July 04, 2018
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Diakonhjemmet Hospital

    Oslo, 0319
    Norway

    Active - Recruiting

  • Orthopedic Center, Ullevål University Hopspital

    Oslo, 0407
    Norway

    Active - Recruiting

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