Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT04717557
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04717557
Study Brief:
Protocol Section:
NCT04717557