Trials / Recruiting
RecruitingNCT03594344
Additional Hyperbaric Oxygen After Lower Extremity Amputation
Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Diabetes Mellitus
- Claudication, Intermittent
- Critical Limb Ischemia
- Osteomyelitis
- Amputation
- Lower Extremity Ulcer
- Diabetic Angiopathy
- Diabetic Neuropathies
- Diabetic Foot
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-07-04
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
- First posted
- 2018-07-20
- Last updated
- 2025-03-30
Locations
2 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT03594344. Inclusion in this directory is not an endorsement.