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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT03384758
Eligibility Criteria:
Inclusion Criteria:
Study-Arm PAD:
* leg edema
* symptomatic PAD (Fontaine stage II)
* no palpable foot pulses
* ABI \<0.9 and \>0.6, absolute ankle pressure \> 60mmHg
Study-Arm Diabetes:
* leg edema
* Diabetes mellitus Typ 2 (history of longer than 2 years)
* palpable foot pulses
* Pallaesthesie \>6
* Wagner Score 0
Exclusion Criteria:
Study-Arm PAD:
* Critical limb ischemia
* ABI \< 0.6
* simoultaneous Diabetes Mellitus
Study-Arm Diabetes:
* Wagner Score \>0
* Pallasthesie \<6
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03384758
Study Brief:
Protocol Section:
NCT03384758