DLapheresis-mediated Endothelial activation Therapy to Severe-Peripheral Artery Disease study
Not Applicable
Recruiting
- Conditions
- conventional therapy-resistant peripheral artery disease (PAD)without hypercholesterolemia
- Registration Number
- JPRN-UMIN000021684
- Lead Sponsor
- Yokohama City University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
(1)uncontrolled diabetes despite insulin therapy (2)severe hepatic disorders (3)inevitable use of ACE inhibitors during the treatment period (4)ineligible patients judged by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The followings are examined at baseline and one month after 10th apheresis: 1)ankle brachial pressure index 2)Vascular Quality of Life Questionnaire scores
- Secondary Outcome Measures
Name Time Method The followings are examined at baseline, one month after 10th apheresis, and three months after 10th apheresis: [clinical examination] (A)objective clinical symptoms (a)walking distance (b)leg ulcers (B)subjective clinical symptoms (a)Vascular Quality of Life Questionnaire (b)leg pain in rest (C)blood examinations (a)serum lipids (b)coagulatory/ inflammatory markers (c)oxidative stress markers (D)gene expression analysis in peripheral white blood cells [physical examination] (a)pulse wave velocity (b)central blood pressure (c)cardio-ankle vascular index (d)endothelium function (reactive hyperemia peripheral arterial tonometry) (e)skin perfusion pressure (f)leg CT angiography (or leg MRA) (g)ankle brachial pressure index [the presence or absence of lower extremity amputation] [the change in Fontaine classification]