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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT03220451
Eligibility Criteria:
Inclusion Criteria:
* Spinal cord injury of any aetiology (traumatic and non-traumatic) and any neurological level, both complete and incomplete, occurred at least 3 months before;
* Pressure ulcer occurred at least 1 month before;
* Pressure ulcer staged III or IV, according to the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel (NPUAP/EPUAP) classification;
* Pressure ulcer located in sacral or heel region;
* Pressure ulcer with cleansed bottom;
* Stable clinical conditions;
* Cognitive integrity and full collaboration of the subject.
Exclusion Criteria:
* Ulcerative skin lesion not due to pressure;
* Pressure ulcer with frank signs of infection or suggestive of underlying osteomyelitis;
* Eczema and/or irritated and/or psoriatic skin around the pressure ulcer;
* Ongoing deep venous thrombosis;
* Known allergy to elastic adhesive tape;
* Ongoing neoplasia;
* Uncompensated diabetes with signs of peripheral vasculopathy;
* Evidence of peripheral polyneuropathy;
* Circulatory problems (e.g. severe lower limb artery disease);
* Significant respiratory problems (e.g. with ongoing assisted ventilation);
* Ongoing sepsis;
* Ongoing severe clinical instability;
* Ongoing oral anticoagulant therapy;
* Ongoing pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03220451
Study Brief:
Protocol Section:
NCT03220451