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NCT Number: NCT03594344

Additional Hyperbaric Oxygen After Lower Extremity Amputation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric Oxygen Therapy

Procedure

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

Primary outcomes

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

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 12 months

    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.

  4. Time to closed and intact skin at the site of amputation

    Time frame: 1 year

    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.

  5. Reamputations

    Time frame: 1 year

    The total number of reamputations done within the follow-up period of 1 year.

  6. Number of wound revision

    Time frame: 1 year

    The total numbers of surgical wound revision done in operating theater.

  7. Days in hospital during follow up

    Time frame: 1 year

    Total number of days in hospital during 1 year follow up

  8. Visual analog pain scale (VAS)

    Time frame: baseline

    Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.

  9. Visual analog pain scale (VAS)

    Time frame: 12 weeks

    Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.

  10. Visual analog pain scale (VAS)

    Time frame: 6 months

    Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.

  11. Visual analog pain scale (VAS)

    Time frame: 1 year

    Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.

  12. RAND 36-Item Short Form Health Survey

    Time frame: baseline

    RAND 36-Item Short Form Health Survey (SF-36) measures 8 health domains with the total of 36 questions. The domains are physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. There is also 1 question that measures change in self-perceived health.The question answers is translated to a number between 0 meaning worst selv-perceived health and 100 meaning the best possible quality of health.Each domain will be presented with a number between 0 and 100.

  13. RAND 36-Item Short Form Health Survey

    Time frame: 12 weeks

    RAND 36-Item Short Form Health Survey (SF-36) measures 8 health domains with the total of 36 questions. The domains are physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. There is also 1 question that measures change in self-perceived health.The question answers is translated to a number between 0 meaning worst selv-perceived health and 100 meaning the best possible quality of health.Each domain will be presented with a number between 0 and 100.

  14. RAND 36-Item Short Form Health Survey

    Time frame: 6 months

    RAND 36-Item Short Form Health Survey (SF-36) measures 8 health domains with the total of 36 questions. The domains are physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. There is also 1 question that measures change in self-perceived health.The question answers is translated to a number between 0 meaning worst selv-perceived health and 100 meaning the best possible quality of health.Each domain will be presented with a number between 0 and 100.

  15. RAND 36-Item Short Form Health Survey

    Time frame: 1 year

    RAND 36-Item Short Form Health Survey (SF-36) measures 8 health domains with the total of 36 questions. The domains are physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. There is also 1 question that measures change in self-perceived health.The question answers is translated to a number between 0 meaning worst selv-perceived health and 100 meaning the best possible quality of health.Each domain will be presented with a number between 0 and 100.

  16. Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form

    Time frame: baseline

    Quality of Life in Neurological Disorders (Neuro-QoL) - Lower extremity function - Mobility Short form measures lower extremity function with 8 items scoring from 1 unable to do, to 5 which is doing it without any difficulty. Scores will be presented as total points from 5-40.

  17. Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form

    Time frame: 12 weeks

    Quality of Life in Neurological Disorders (Neuro-QoL) - Lower extremity function - Mobility Short form measures lower extremity function with 8 items scoring from 1 unable to do, to 5 which is doing it without any difficulty. Scores will be presented as total points from 5-40.

  18. Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form

    Time frame: 6 months

    Quality of Life in Neurological Disorders (Neuro-QoL) - Lower extremity function - Mobility Short form measures lower extremity function with 8 items scoring from 1 unable to do, to 5 which is doing it without any difficulty. Scores will be presented as total points from 5-40.

  19. Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form

    Time frame: 1 year

    Quality of Life in Neurological Disorders (Neuro-QoL) - Lower extremity function - Mobility Short form measures lower extremity function with 8 items scoring from 1 unable to do, to 5 which is doing it without any difficulty. Scores will be presented as total points from 5-40.

  20. The Foot and Ankle Ability Measure (FAAM)

    Time frame: baseline

    The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. FAAM contains 21 items that measure different functions. Each answer get a score from 0 to 4. The score total will be reported were 0 is the lowest and 84 is the highest possible score.

  21. The Foot and Ankle Ability Measure (FAAM)

    Time frame: 12 weeks

    The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. FAAM contains 21 items that measure different functions. Each answer get a score from 0 to 4. The score total will be reported were 0 is the lowest and 84 is the highest possible score.

  22. The Foot and Ankle Ability Measure (FAAM)

    Time frame: 6 months

    The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. FAAM contains 21 items that measure different functions. Each answer get a score from 0 to 4. The score total will be reported were 0 is the lowest and 84 is the highest possible score.

  23. The Foot and Ankle Ability Measure (FAAM)

    Time frame: 1 year

    The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. FAAM contains 21 items that measure different functions. Each answer get a score from 0 to 4. The score total will be reported were 0 is the lowest and 84 is the highest possible score.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth I Ellingsen Husebye, MD, PhD

CONTACT

[email protected]

+47 95133773 ext. +47 95133773

Jonas Rydinge, MD

CONTACT

[email protected]

+4792291795 ext. +47 92291795

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Diakonhjemmet Hospital

Registry information

Official study title

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

Acronym: AHOLEA

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Jul 20, 2018
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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