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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT06186505
Eligibility Criteria:
Participants in Phase 1a will be healthy volunteers. The inclusion criteria for this cohort are:
* Aged 18 or over
* ABPI within normal range (0.9 - 1.2)
* Negative Edinburgh Claudication Questionnaire
For Phase 1b and 1c inclusion criteria are:
* Capacity to provide informed consent
* Aged 60 or over
* ABPI \<0.9
* Positive Edinburgh Claudication Questionnaire
Exclusion Criteria:
* Aged under 60 years (for Phase 1b and 1c only)
* Has known allergy to any trial product
* undergone previous surgical or endovascular intervention for peripheral arterial or endovascular intervention for peripheral arterial disease
* Alternative cause of leg pain
* Requires urgent revascularisation (\<2 weeks)
* Significant leg ulceration/necrosis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06186505
Study Brief:
Protocol Section:
NCT06186505