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Additional Hyperbaric Oxygen After Lower Extremity Amputation (AHOLEA)

Primary Purpose

Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetic foot, Diabetes, Lower extremity amputation, Hyperbaric oxygen therapy, HBOT

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diakonhjemmet HospitalRecruiting
  • Orthopedic Center, Ullevål University HopspitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hyperbaric oxygen therapy

Control group

Arm Description

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.

Control group will be given standard of care with follow up at the outpatient clinic after discharge from hospital.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2018
Last Updated
March 21, 2023
Sponsor
Oslo University Hospital
Collaborators
Diakonhjemmet Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03594344
Brief Title
Additional Hyperbaric Oxygen After Lower Extremity Amputation
Acronym
AHOLEA
Official Title
Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Diakonhjemmet Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric oxygen therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will be given standard of care with follow up at the outpatient clinic after discharge from hospital.
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric oxygen therapy
Intervention Description
Breathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions
Primary Outcome Measure Information:
Title
Intact skin with no abnormal openings at the site of primary amputation
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Intact skin with no abnormal openings at the site of amputation at 6 months
Description
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.
Time Frame
6 months
Title
Intact skin with no abnormal openings at the site of amputation at 9 months
Description
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.
Time Frame
9 months
Title
Intact skin with no abnormal openings at the site of amputation at 1 year
Description
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.
Time Frame
12 months
Title
Time to closed and intact skin at the site of amputation
Description
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.
Time Frame
1 year
Title
Reamputations
Description
The total number of reamputations done within the follow-up period of 1 year.
Time Frame
1 year
Title
Number of wound revision
Description
The total numbers of surgical wound revision done in operating theater.
Time Frame
1 year
Title
Days in hospital during follow up
Description
Total number of days in hospital during 1 year follow up
Time Frame
1 year
Title
Visual analog pain scale (VAS)
Description
Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.
Time Frame
baseline
Title
Visual analog pain scale (VAS)
Description
Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.
Time Frame
12 weeks
Title
Visual analog pain scale (VAS)
Description
Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.
Time Frame
6 months
Title
Visual analog pain scale (VAS)
Description
Visual analog pain scale (VAS) is a measurement of pain intensity between 0 and 10. 0 = no pain, 10 = worst imaginable pain.
Time Frame
1 year
Title
RAND 36-Item Short Form Health Survey
Description
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.
Time Frame
baseline
Title
RAND 36-Item Short Form Health Survey
Description
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.
Time Frame
12 weeks
Title
RAND 36-Item Short Form Health Survey
Description
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.
Time Frame
6 months
Title
RAND 36-Item Short Form Health Survey
Description
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.
Time Frame
1 year
Title
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
Description
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.
Time Frame
baseline
Title
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
Description
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.
Time Frame
12 weeks
Title
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
Description
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.
Time Frame
6 months
Title
Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form
Description
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.
Time Frame
1 year
Title
The Foot and Ankle Ability Measure (FAAM)
Description
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.
Time Frame
baseline
Title
The Foot and Ankle Ability Measure (FAAM)
Description
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.
Time Frame
12 weeks
Title
The Foot and Ankle Ability Measure (FAAM)
Description
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.
Time Frame
6 months
Title
The Foot and Ankle Ability Measure (FAAM)
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonas Thomassen, MD
Phone
+47 99621124
Email
jonas_thomassen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas Thomassen, MD
Organizational Affiliation
Ullevål University Hospital, orthopedic department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0319
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mads Sundet, MD
Phone
+4741661770
Email
mads.sundet@icloud.com
First Name & Middle Initial & Last Name & Degree
Mads Sundet, MD
Facility Name
Orthopedic Center, Ullevål University Hopspital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Ellingsen Husebye, MD, phD
Phone
+47 23027884
First Name & Middle Initial & Last Name & Degree
Jonas Thomassen
Phone
+47 99621124
Email
jonas_thomassen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Elisabeth Ellingsen Husebye, MD
First Name & Middle Initial & Last Name & Degree
Jonas Thomassen, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Additional Hyperbaric Oxygen After Lower Extremity Amputation

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