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Additional Hyperbaric Oxygen After Lower Extremity Amputation

ConditionsDiabetes MellitusClaudication, IntermittentCritical Limb IschemiaOsteomyelitisAmputationLower Extremity UlcerDiabetic AngiopathyDiabetic NeuropathiesDiabetic Foot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorOslo University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Not fulfilling inclusion criteria

Pregnancy

Dementia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperbaric oxygen therapy

    Procedure/Surgery

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Hyperbaric oxygen therapyExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Intact skin with no abnormal openings at the site of primary amputation

Healed and intact skin at the site of primary amputation without need for more proximal amputation.Healed amputation is defined as epithelialization of the wound examined by a orthopedic surgeon. Level of primary amputation is decided by the surgeon. Planned 2-session amputation, for example Guillotine amputation with a final amputation later is considered being primary amputation. Healed primary amputation will be measured at 12 weeks.

Time frame
12 weeks

Secondary outcomes

1

Intact skin with no abnormal openings at the site of amputation at 6 months

Healed and intact skin at the site of amputation at follow up 6 months. Healed amputation is defined as epithelialization of the wound examined by a orthopedic surgeon.

Time frame
6 months
2

Intact skin with no abnormal openings at the site of amputation at 9 months

Healed and intact skin at the site of amputation at follow up 9 months. Will be assessed if the wound has not healed at 6 months. Healed amputation is defined as epithelialization of the wound examined by a orthopedic surgeon.

Time frame
9 months
3

Intact skin with no abnormal openings at the site of amputation at 1 year

Healed and intact skin at the site of amputation at follow up at 1 year. Healed amputation is defined as epithelialization of the wound examined by a orthopedic surgeon.

Time frame
12 months
4

Time to closed and intact skin at the site of amputation

Time to closed and intact skin at the site of amputation is the defined as how many weeks until complete healing of amputation. Healed amputation is defined as epithelialization of the wound examined by a orthopedic surgeon and no abnormal openings.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oslo University Hospital

Lead sponsor

Diakonhjemmet Hospital

Collaborator

Source ClinicalTrials.gov
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