Study of Hyperbaric Oxygen Therapy After Lower Leg Amputation to Improve Healing and Mobility

What this Trial Is About

Researchers are evaluating the effect of adding hyperbaric oxygen therapy after lower extremity amputation. The study focuses on patients who have had amputations due to chronic wounds, osteomyelitis, ischemia, or necrosis, conditions commonly associated with poor healing. Hyperbaric oxygen therapy has been used for decades to help heal difficult wounds by increasing oxygen levels in tissues, potentially improving healing at the amputation site and reducing the need for further amputations. Participants who have undergone lower extremity amputation will be randomly assigned to one of two groups. One group will receive 30 sessions of hyperbaric oxygen therapy, each lasting 90 minutes at 2.4 atmosphere absolute ATA with 100% oxygen. The first treatment must begin within seven days after amputation, and the therapy is provided as outpatient care after hospital discharge. The other group will receive standard care and outpatient follow-up without hyperbaric oxygen therapy. During the study, participants will be monitored for skin healing at the amputation site up to 12 months, including assessments at 12 weeks, 6 months, 9 months, and 1 year. Researchers will measure outcomes like intact skin without abnormal openings, time to wound closure, reamputations, wound revisions, hospital days, pain levels, quality of life, mobility, and foot and ankle function. Follow-up visits and evaluations will occur regularly to track healing progress and overall health after treatment.

Additional Hyperbaric Oxygen After Lower Extremity Amputation