Hyperbaric Oxygen Therapy to Prevent Complications After Lower Limb Amputation

Pro00093687

This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications. It is hypothesized that HBO2 given in the immediate postoperative period will reduce postoperative complications in patients undergoing below-the-knee amputations. The objective of this study will be to compare treatment and standard care groups, randomly created of eligible patients, to compare their postoperative complications and to assess their postoperative hospital length of stay, 90-day mortality, failure to heal at 4 and 8 week follow-up visits and ability to ambulate with a prosthesis at 6 months post amputation.

2021-01-01

2024-12-31

2024-12-31

Recruiting

Early phase I

140

Inclusion Criteria: * Able to consent * Non-traumatic indication for lower limb amputation * Able to receive hyperbaric oxygen therapy Exclusion Criteria: * Unable to consent * Contraindication to hyperbaric oxygen * End stage renal disease on dialysis * Current renal failure as measured by creatinine levels vs baseline change of more than 1 mg/dL and for whom dialysis is expected to be required with the next month * Calciphylaxis * Traumatic injuries that are the cause of the amputation * Cancer being treated by chemotherapy, scheduled to be treated, or being treated or scheduled to be treated by radiation. * Limb amputation secondary to ischemic complications from other operations * Second amputation or reoperation on prior amputation * Pregnancy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Permuted block', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2023-07-03