Diabetes MellitusAHOLEANCT03594344
Additional Hyperbaric Oxygen After Lower Extremity Amputation
A study testing Hyperbaric oxygen therapy in people with Diabetes Mellitus and Claudication, Intermittent, run by Oslo University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesNorway
- Study dates
- 4 Jul 2018to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not fulfilling inclusion criteria
- Pregnancy
- Dementia
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Diakonhjemmet Hospital
Oslo, 0319
Mads Sundet, MD, +4741661770, mads.sundet@icloud.com
Mads Sundet, MD
- Recruiting
Orthopedic Center, Ullevål University Hopspital
Oslo, 0407
Elisabeth Ellingsen Husebye, MD, PhD, +47 23027884
Jonas Rydinge, +47 92291795 ext. +47 92291795, jonryd@ous-hf.no
About this study
Official title: Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis, Amputation, Lower Extremity Ulcer
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- Diabetic foot, Diabetes, Lower extremity amputation, Hyperbaric oxygen therapy, HBOT
- Medical subject headings
- Diabetes Mellitus, Intermittent Claudication, Chronic Limb-Threatening Ischemia, Osteomyelitis, Leg Ulcer, Diabetic Angiopathies, Diabetic Neuropathies, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyProcedure or surgery
Breathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | 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. Receives: Procedure: Hyperbaric oxygen therapy |
| Control group | No intervention | Control group will be given standard of care with follow up at the outpatient clinic after discharge from hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (23)
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: 12 months
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.
Measured: 1 year
Reamputations
The total number of reamputations done within the follow-up period of 1 year.
Measured: 1 year
Number of wound revision
The total numbers of surgical wound revision done in operating theater.
Measured: 1 year
Days in hospital during follow up
Total number of days in hospital during 1 year follow up
Measured: 1 year
Visual analog pain scale (VAS)
Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.
Measured: baseline
Visual analog pain scale (VAS)
Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.
Measured: 12 weeks
Visual analog pain scale (VAS)
Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.
Measured: 6 months
Visual analog pain scale (VAS)
Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.
Measured: 1 year
RAND 36-Item Short Form Health Survey
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.
Measured: baseline
RAND 36-Item Short Form Health Survey
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.
Measured: 12 weeks
RAND 36-Item Short Form Health Survey
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.
Measured: 6 months
RAND 36-Item Short Form Health Survey
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.
Measured: 1 year
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
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.
Measured: baseline
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
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.
Measured: 12 weeks
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
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.
Measured: 6 months
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
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.
Measured: 1 year
The Foot and Ankle Ability Measure (FAAM)
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.
Measured: baseline
The Foot and Ankle Ability Measure (FAAM)
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.
Measured: 12 weeks
The Foot and Ankle Ability Measure (FAAM)
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.
Measured: 6 months
The Foot and Ankle Ability Measure (FAAM)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start4 Jul 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonhjemmet Hospital
- Responsible party
- Principal investigator, Elisabeth Ellingsen Husebye, Oslo University Hospital
- Investigators
- Jonas V Rydinge, MD, Principal investigator, Ullevål University Hospital, orthopedic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594344
- Sponsor's protocol ID
- 2017/1587
- Acronym
- AHOLEA
- Status last verified
- Sep 2024
- First submitted
- 15 Jun 2018
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03594344
- Acronym / sponsor ID
- AHOLEA / 2017/1587
- Conditions
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis, Amputation, Lower Extremity Ulcer
- Keywords
- Diabetic foot, Diabetes, Lower extremity amputation, Hyperbaric oxygen therapy, HBOT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Diakonhjemmet Hospital
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Procedure: Hyperbaric oxygen therapy30 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. |
| Control group | No intervention | –Control group will be given standard of care with follow up at the outpatient clinic after discharge from hospital. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Not fulfilling inclusion criteria
- Pregnancy
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyBreathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions | Procedure or surgery | Hyperbaric oxygen therapy |
Primary outcome
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.
23 secondary outcomes
Intact skin with no abnormal openings at the site of amputation at 6 months
Time frame: 6 months
Intact skin with no abnormal openings at the site of amputation at 9 months
Time frame: 9 months
Intact skin with no abnormal openings at the site of amputation at 1 year
Time frame: 12 months
Time to closed and intact skin at the site of amputation
Time frame: 1 year
Reamputations
Time frame: 1 year
Number of wound revision
Time frame: 1 year
Days in hospital during follow up
Time frame: 1 year
Visual analog pain scale (VAS)
Time frame: baseline
Visual analog pain scale (VAS)
Time frame: 12 weeks
Visual analog pain scale (VAS)
Time frame: 6 months
Visual analog pain scale (VAS)
Time frame: 1 year
RAND 36-Item Short Form Health Survey
Time frame: baseline
RAND 36-Item Short Form Health Survey
Time frame: 12 weeks
RAND 36-Item Short Form Health Survey
Time frame: 6 months
RAND 36-Item Short Form Health Survey
Time frame: 1 year
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
Time frame: baseline
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
Time frame: 12 weeks
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
Time frame: 6 months
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
Time frame: 1 year
The Foot and Ankle Ability Measure (FAAM)
Time frame: baseline
The Foot and Ankle Ability Measure (FAAM)
Time frame: 12 weeks
The Foot and Ankle Ability Measure (FAAM)
Time frame: 6 months
The Foot and Ankle Ability Measure (FAAM)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonas V Rydinge, MD principal investigator
Ullevål University Hospital, orthopedic department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy in people with Diabetes Mellitus and Claudication, Intermittent, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonas Rydinge, MD (+4792291795 ext. +47 92291795, jonryd@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intact skin with no abnormal openings at the site of primary amputation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.