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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT03463434
Eligibility Criteria:
Inclusion Criteria:
1. Patient's treatment goals are curative or maintaining, and not palliative in nature.
2. Patient is compliant with standard clinical care for their admitted condition.
3. Patient's age is between 18 and 85 years
4. Patient is expected to have at least a 3-4-week length of stay (from date of assessment) in the treating LTACH
5. Patient must have at least one stage 3 or 4 PI located on the weight bearing aspect of the patient's truncal /pelvic region
6. Patients or their legal authorized representative must be willing and able to provide written informed consent.
Exclusion Criteria:
1. Patient has an unstable spinal cord injury
2. Patient weighs less than 70 lbs or more than 350 lbs.
3. The primary study PI site has had previous flaps or grafts with significant associated scarring which is clinically thought to impede wound contracture.
4. Patients with PIs where bone exposure is \> 2 cm2 in area.
5. Patients with active osteomyelitis (via clinical assessment) or patients who have been diagnosed with osteomyelitis and have not yet completed a 6-8-week course of antibiotics
6. The primary study PI is located over the trochanteric head of the femur.
7. Patients that are currently taking or have taken in the last 6 weeks chemotherapy which is known to be cyto-toxic, or anti-angiogenic
8. Patients currently require immune modulating drugs (Humira (alalimumab), Orencia (abatacept), etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03463434
Study Brief:
Protocol Section:
NCT03463434