Clinical trial NCT03594344: Additional Hyperbaric Oxygen After Lower Extremity Amputation
Official title: Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Claudication, Intermittent
Critical Limb Ischemia
Osteomyelitis
Amputation
Lower Extremity Ulcer
Diabetic Angiopathy
Diabetic Neuropathies
Diabetic Foot
Keywords: Diabetic foot
Diabetes
Lower extremity amputation
Hyperbaric oxygen therapy
HBOT
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Diakonhjemmet Hospital
First posted: 2018-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 criteria: 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

Primary outcomes:
measure: Intact skin with no abnormal openings at the site of primary amputation
timeFrame: 12 weeks
Secondary outcomes:
measure: Intact skin with no abnormal openings at the site of amputation at 6 months
timeFrame: 6 months
measure: Intact skin with no abnormal openings at the site of amputation at 9 months
timeFrame: 9 months
measure: Intact skin with no abnormal openings at the site of amputation at 1 year
timeFrame: 12 months
measure: Time to closed and intact skin at the site of amputation
timeFrame: 1 year
measure: Reamputations
timeFrame: 1 year
measure: Number of wound revision
timeFrame: 1 year
measure: Days in hospital during follow up
timeFrame: 1 year
measure: Visual analog pain scale (VAS)
timeFrame: baseline
measure: Visual analog pain scale (VAS)
timeFrame: 12 weeks
measure: Visual analog pain scale (VAS)
timeFrame: 6 months
measure: Visual analog pain scale (VAS)
timeFrame: 1 year
measure: RAND 36-Item Short Form Health Survey
timeFrame: baseline
measure: RAND 36-Item Short Form Health Survey
timeFrame: 12 weeks
measure: RAND 36-Item Short Form Health Survey
timeFrame: 6 months
measure: RAND 36-Item Short Form Health Survey
timeFrame: 1 year
measure: Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
timeFrame: baseline
measure: Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
timeFrame: 12 weeks
measure: Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
timeFrame: 6 months
measure: Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
timeFrame: 1 year
measure: The Foot and Ankle Ability Measure (FAAM)
timeFrame: baseline
measure: The Foot and Ankle Ability Measure (FAAM)
timeFrame: 12 weeks
measure: The Foot and Ankle Ability Measure (FAAM)
timeFrame: 6 months
measure: The Foot and Ankle Ability Measure (FAAM)
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Oslo
country: Norway
facility: Orthopedic Center, Ullevål University Hopspital
Study officials:
affiliation: Ullevål University Hospital, orthopedic department
name: Jonas V Rydinge, MD
role: PRINCIPAL_INVESTIGATOR
References: