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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00243620
Eligibility Criteria:
Inclusion Criteria:
patient with a chronic leg ulcer (\> 6 months) without healing signs and satisfies to one or more criteria:
* Venous (venous insufficiency of the deep or superficial system without an arterial incompetence)
* Combined venous/arterial (venous insufficiency of the deep or superficial system with an ankle/brachial index of 0·60 - 0·85)
* Arteriolosclerotic (Martorell's ulcer) leg ulcers (diagnose made by anamnesis, clinical signs, exclusions of differential diagnosis's, venous/ arterial duplex shows no signs of obstruction or major venous insufficiency, histology)
Exclusion Criteria:
1. ulcer duration shorter than 6 months
2. age \> 85 years
3. use of immune suppressive medication
4. known type IV allergies against ingredients of the wound care products
5. insulin-dependent diabetes mellitus type I
6. severe peripheral arterial disease (ankle/brachial index \<0·60)
7. vasculitic ulcers
8. neoplastic ulcers.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
85 Years
Study:
NCT00243620
Study Brief:
Protocol Section:
NCT00243620