Additional Hyperbaric Oxygen After Lower Extremity Amputation (AHOLEA)

University of Oslo (UIO)

Status: Enrolling

Conditions: Claudication, Intermittent; Diabetic Foot; Critical Limb Ischemia; Lower Extremity Ulcer; Diabetes Mellitus; Osteomyelitis; Diabetic Neuropathies; Amputation; Diabetic Angiopathy

Treatments: Procedure: Hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03594344

2017/1587

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Hyperbaric oxygen therapy

Experimental group

Description:

30 sessions of Hyperbaric oxygen therapy, 90min treatment at 2,4 ATA(atmosphere absolute) with 100% oxygen.First session must be given within 7 days after initial amputation. Treatment is given as outpatient treatment after discharge from hospital.

Treatment:

Procedure: Hyperbaric oxygen therapy

Control group

No Intervention group

Description:

Control group will be given standard of care with follow up at the outpatient clinic after discharge from hospital.