RecruitingNot ApplicableNCT03594344

Additional Hyperbaric Oxygen After Lower Extremity Amputation

Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial


Sponsor

Oslo University Hospital

Enrollment

120 participants

Start Date

Jul 4, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether adding hyperbaric oxygen therapy (HBOT) after lower limb amputation helps patients heal better and reduces wound complications. HBOT involves breathing pure oxygen inside a pressurized chamber, which dramatically increases oxygen delivery to tissues and may promote wound healing. Lower extremity amputations — often due to diabetes, infection, poor blood circulation, or tissue death — carry significant risks of wound complications and rehospitalization. HBOT is already used in some wound care settings, and this trial specifically tests its benefit after amputation surgery. Adults aged 18–90 who have undergone a lower limb amputation for qualifying reasons and who are enrolled within 7 days of their final surgery are eligible. You may be eligible if you: - Are between 18 and 90 years of age - Have had a lower extremity amputation due to chronic wound, osteomyelitis (bone infection), ischemia (poor blood flow), or necrosis (tissue death) - Have been cleared for hyperbaric oxygen therapy by an anesthesiologist or Hyperbaric Medicine Physician - Can attend follow-up appointments - Are enrolled within 7 days of your final surgery You may NOT be eligible if you: - Are currently pregnant - Have dementia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHyperbaric oxygen therapy

Breathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions


Locations(2)

Diakonhjemmet Hospital

Oslo, Norway

Orthopedic Center, Ullevål University Hopspital

Oslo, Norway

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NCT03594344


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