Additional Hyperbaric Oxygen After Lower Extremity Amputation (AHOLEA)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Diabetic Foot; Diabetic Neuropathies; Amputation; Critical Limb Ischemia; Osteomyelitis; Claudication, Intermittent; Lower Extremity Ulcer; Diabetic Angiopathy
• Intervention / Treatment: Procedure: Hyperbaric oxygen therapy

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonas Rydinge, MD; Phone Number: +47 92291795 +4792291795; Email: jonryd@ous-hf.no
• Study Contact Backup: Name: Elisabeth I Ellingsen Husebye, MD, PhD; Phone Number: +47 95133773 +47 95133773; Email: uxngng@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0319
    • Recruiting
    • Diakonhjemmet Hospital
    • Contact: Mads Sundet, MD; Phone Number: +4741661770; Email: mads.sundet@icloud.com
    • Contact: Mads Sundet, MD
  • Oslo, Norway, 0407
    • Recruiting
    • Orthopedic Center, Ullevål University Hopspital
    • Contact: Elisabeth Ellingsen Husebye, MD, PhD; Phone Number: +47 23027884
    • Contact: Jonas Rydinge; Phone Number: +47 92291795 +47 92291795; Email: jonryd@ous-hf.no
    • Contact: Jonas Rydinge, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperbaric oxygen therapy; 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.	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
No Intervention: Control group; Control group will be given standard of care with follow up at the outpatient clinic after discharge from hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Reamputations	The total number of reamputations done within the follow-up period of 1 year.	1 year
Number of wound revision	The total numbers of surgical wound revision done in operating theater.	1 year
Days in hospital during follow up	Total number of days in hospital during 1 year follow up	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Diakonhjemmet Hospital
• Investigators: Principal Investigator: Jonas V Rydinge, MD, Ullevål University Hospital, orthopedic department

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Diabetic foot; Lower extremity amputation; Hyperbaric oxygen therapy; HBOT
• Additional Relevant MeSH Terms: Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Infections; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Complications; Bone Diseases, Infectious; Skin Diseases; Skin Ulcer; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Foot Ulcer; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Leg Ulcer; Diabetic Neuropathies; Diabetic Foot; Intermittent Claudication; Osteomyelitis; Diabetic Angiopathies
• Other Study ID Numbers: 2017/1587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No