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 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT04829812
Eligibility Criteria:
Inclusion criteria:
* Patient taken care of by a vascular specialist
* Practicing, in a hospital or not or in a healing center,
* Caring for patients with leg ulcers requiring the indication of compression treatment,
* Can include consecutive patients at each consultation over the entire duration of the study or at a pre-established rate of at least half a day per week
* Patient with a chronic leg wound (leg ulcer and foot ulcer), defined as a chronic leg wound that does not spontaneously tend to heal after 6 weeks in the case of a first episode or 2 weeks in the case of recurrenceo In principle justifying a compression treatment, o And concomitantly presenting with PAD, retained by the investigator according to clinical and hemodynamic criteria that he will describe.
Exclusion criteria:
* Patient not giving his consent for collection of study data
* Patient with a life expectancy of less than 6 months.
* Patients for whom telephone follow-up is impossible (no contact possible with the patient, family and friends, IDE and the doctor)
* Patient presenting:
* A leg wound that is not chronic, or does not validate the ulcer criteria;
* An ulcer not located on the leg, in particular trophic disorders above the knee;
* Necrotic angiodermatitis
* Systemic sclerosis
* An infected ulcer (not temporary)
* An arterial ulcer, with PAD at the critical ischemia stage (ICC 2020 consensus), ABI\<0.6, systolic ankle pression \<60mmHg, systolic toe pression\<30mmHg, TCPO2\<20mmHg, bypass of lower limbs
* Patients for whom compression is not an option, regardless of arteriopathy, especially in cases of:
* Allergy or intolerance to compression equipment
* Practical or organizational installation difficulties
* Morphotype difficult to fit (due to obesity, cachexia, trauma, dermatosis or other ...).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04829812
Study Brief:
Protocol Section:
NCT04829812