Additional Hyperbaric Oxygen After Lower Extremity Amputation

Diabetes Mellitus Clinical Trial

— AHOLEA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594344
• Other study ID #: 2017/1587
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Oslo University Hospital
• Contact: Jonas Thomassen, MD
• Phone: +47 99621124
• Email: jonas_thomassen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Claudication, Intermittent
• Critical Limb Ischemia
• Diabetes Mellitus
• Diabetic Angiopathies
• Diabetic Angiopathy
• Diabetic Foot
• Diabetic Neuropathies
• Intermittent Claudication
• Ischemia
• Leg Ulcer
• Lower Extremity Ulcer
• Osteomyelitis

Intervention

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

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo
Norway	Orthopedic Center, Ullevål University Hopspital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	6 months
Secondary	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.	9 months
Secondary	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.	12 months
Secondary	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.	1 year
Secondary	Reamputations	The total number of reamputations done within the follow-up period of 1 year.	1 year
Secondary	Number of wound revision	The total numbers of surgical wound revision done in operating theater.	1 year
Secondary	Days in hospital during follow up	Total number of days in hospital during 1 year follow up	1 year
Secondary	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.	baseline
Secondary	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.	12 weeks
Secondary	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.	6 months
Secondary	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.	1 year
Secondary	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.	baseline
Secondary	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.	12 weeks
Secondary	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.	6 months
Secondary	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.	1 year
Secondary	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.	baseline
Secondary	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.	12 weeks
Secondary	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.	6 months
Secondary	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.	1 year
Secondary	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.	baseline
Secondary	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.	12 weeks
Secondary	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.	6 months
Secondary	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.	1 year