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 @ 4:47 AM
Ignite Modification Date:
2025-12-25 @ 4:47 AM
NCT ID:
NCT00189618
Eligibility Criteria:
Inclusion Criteria:
1. Inclusion criteria for CD stability testing:
* Patients of both sexes with subjectively reported initial claudication distances between 50 and 500 m
* Patients with treadmill tested initial claudication distances between 50 and 400 m
* History of intermittent claudication \> 3 months
* Established PAD diagnosis (ABI reference leg \< 0.95 in non-diabetics, TBI reference leg \< 0.70 in diabetics)
* CLI ruled-out (ankle pressures \> 50 mmHg (non diabetics), toe pressures \> 30 mmHg (diabetics))
* Stabilized treatment of concomitant diseases
2. Inclusion criteria for randomized treatment phase:
* Patients of both sexes with treadmill tested initial claudication distances between 50 and 400 m
* ICD variability during stability testing phase less than 25 %
* History of intermittent claudication \> 3 months
* Established PAD diagnosis (ABI reference leg \< 0.95 in non-diabetics, TBI reference leg \< 0.70 in diabetics)
* CLI ruled-out (ankle pressures \> 50 mmHg (non diabetics), toe pressures \> 30 mmHg (diabetics))
* Stabilized treatment of concomitant diseases
* Written informed consent
Exclusion Criteria:
* Treatment with oral anticoagulants (except those cases, where the parallel treatment with a platelet aggregation inhibitor (ASA, Clopidogrel) and an oral anticoagulant is medically indicated and justified)
* Lower extremity surgical reconstruction or PTA within the last 3 months
* Age \< 45 years old (M), childbearing potential (F)
* Buerger's disease
* Clinically evident peripheral polyneuropathy (sensibility to vibration \< 4/8, ATR not revocable)
* Presence of orthopedic, cardiac, pulmonary, or other concomitant diseases interfering with or preventing steady walking on a treadmill
* Clinically manifested congestive cardiac failure (NYHA class II - IV)
* Pretreatment with vasotherapeutics within the last 4 weeks prior to recruitment to the study without appropriate wash-out (\> 5 half life times of the vasoactive drug)
* Consuming disease with life expectancy of less than 2 years
* Noncompliance of patient due to personality disorders or concomitant disease
* Known ASA or Clopidogrel intolerance
* Conditions requiring the regular intake of non-steroidal anti-inflammatory drugs
* Peptic ulcer within the previous 6 months
* History of GI or any other bleeding disorder within the previous 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
95 Years
Study:
NCT00189618
Study Brief:
Protocol Section:
NCT00189618