Amputation, Claudication, Intermittent, Critical Limb Ischemia, Diabetes Mellitus, Diabetic Angiopathy, Diabetic Foot, Diabetic Neuropathies, Lower Extremity Ulcer, Osteomyelitis
Conditions
Keywords
Diabetic foot, Diabetes, Lower extremity amputation, Hyperbaric oxygen therapy, HBOT
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.
Interventions
PROCEDUREHyperbaric oxygen therapy
Breathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions
Sponsors
Diakonhjemmet Hospital
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intact skin with no abnormal openings at the site of primary amputation | 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
| Measure | Time frame | Description |
|---|---|---|
| Intact skin with no abnormal openings at the site of amputation at 9 months | 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 | 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. |
| Time to closed and intact skin at the site of amputation | 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. |
| Reamputations | 1 year | The total number of reamputations done within the follow-up period of 1 year. |
| Number of wound revision | 1 year | The total numbers of surgical wound revision done in operating theater. |
| Intact skin with no abnormal openings at the site of amputation at 6 months | 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. |
| Visual analog pain scale (VAS) | baseline | 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 | 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. |
| Quality of Life in Neurological Disorders - Lower extremity function - Mobility Short form | 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. |
| The Foot and Ankle Ability Measure (FAAM) | 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. |
| Days in hospital during follow up | 1 year | Total number of days in hospital during 1 year follow up |
Countries
Norway
Contacts
Primary ContactJonas Rydinge, MD
Backup ContactElisabeth I Ellingsen Husebye, MD, PhD
Outcome results
None listed