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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02866708
Eligibility Criteria:
We will perform convenience sampling of spinal cord injured patients with leg ulcers, recruited through health professionals affiliated with Sunnaas Rehabilitation hospital.
Inclusion Criteria:
* Able and willing to provide informed consent
* Age: 18-96 years
* Affected foot/shoe size \<46 (approximate foot length\< 29,5 cm)
* Spinal cord injury preferably with a non-healing leg/foot ulcer/pressure wound for more than 6 weeks
Exclusion Criteria:
* Incapable to consent voluntarily, i.e. patients who are not able to consent due to their mental status, or who are not willing or able to perform the negative pressure therapy in a sitting position
* Not adhering to the INP therapy program
* Patients with an expected life-span less than 3 months
* Patients in which a deep venous thrombosis or pulmonary embolism is suspected
* Bilateral amputation of lower extremity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
96 Years
Study:
NCT02866708
Study Brief:
Protocol Section:
NCT02866708