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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT02521220
Eligibility Criteria:
Inclusion Criteria:
* 40 years or older males and postmenopausal women;
* male participants must agree to using an adequate form of contraception during the study period;
* 6-month history of stable intermittent claudication (IC) due to PAD;
* PAD secondary to atherosclerosis with significant claudication (Fontaine class II defined as IC, or Fontaine class III defined as pain at rest);
* IC characterised by pain, ache, cramp, numbness or severe fatigue involving muscles of one or both lower extremities, reproducibly provoked by walking and relieved by rest;
* ankle-brachial index (ABI) at rest of \<0.9 and at least 25% decrease in ABI within 1 min during exercise recovery;
* capacity to walk more than 2 min/15 meters but no more than 12 min on a treadmill using the Skinner-Gardner protocol;
* walking limited by claudication, not coexisting conditions; and
* difference between two consecutive baseline exercise treadmill tests of \<25% during the 3-weeks run-in period; and
* no change in medications or physical activity within 3 months prior to enrolment.
Exclusion Criteria:
* Women of child-bearing potential;
* Current enrolment in another clinical trial and/or ingestion of another investigational product within the past 30 days before enrolment;
* PAD of non-atherosclerotic nature;
* Fontaine class IV i.e. ulcer or gangrene;
* leg amputation above the ankle;
* peripheral vascular surgery, sympathectomy, peripheral angioplasty or stent insertion within the previous 3 months;
* myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within the previous 3 months;
* uncontrolled hypertension (resting systolic blood pressure (SBP) \>190 or diastolic blood pressure (DBP) \>115 mmHg);
* hypotension (SBP \<90mmHg);
* type I diabetes, proliferative retinopathy;
* history of disease state or surgery that affects gastrointestinal absorption;
* significant renal disease (serum creatinine \>3.0 mg/dl);
* liver disease (transaminase \> 3x upper limit of normal, bilirubin \>1.5 times upper limits of normal);
* history of treatment for any malignancy within the past 5 years, or evidence of active malignancy other than squamous cells or basal cell carcinoma of the skin;
* serious infection or hypotension associated with sepsis in the last month;
* cerebrovascular infarct in the last 3 months;
* autoimmune disorders (e.g. systemic lupus erythematosis, ulcerative colitis);
* any other acute or chronic medical condition that in the opinion of the investigators increases the likelihood that the participant would be unable to complete the study;
* unwillingness to discontinue arginine- or L-citrulline-containing products, pentoxifylline, L-carnitine, or prostacyclin for at least 1 month prior to and during the study; and
* conditions other than PAD that limit walking distance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02521220
Study Brief:
Protocol Section:
NCT02521220