Eligibility Module

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: 2025-12-25 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 12:43 AM
NCT ID: NCT01139567
Eligibility Criteria: Inclusion Criteria * Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements: * neuropathic diabetic foot ulcer * soft tissue radiation necrosis * crush injury * compromised/failed skin grafts and flaps * Subjects must have signed the Informed Consent Forms. Exclusion Criteria * Subjects who are not candidates for HBO therapy for any reason, including but not limited to: untreated pneumothorax, uncontrolled congestive heart failure, seizure disorder, neoplastic tumors, claustrophobia (for those in the HBO Group). * Female subjects who are pregnant or nursing. * Anyone who is unable to give written informed consent. * Subjects with end-stage renal disease or who require peritoneal or hemodialysis. * Subjects with current malignancies.
Healthy Volunteers: False
Sex: ALL
Minimum Age: 21 Years
Study: NCT01139567
Study Brief:
Protocol Section: NCT01139567