Using rheopheresis to treat peripheral artery disease in hemodialysis patients
Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients: a Prospective Randomized Single-blind Trial
This study is testing if a new treatment called rheopheresis can help improve blood flow and limb health in hemodialysis patients with severe peripheral artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT03975946 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and tolerance of rheopheresis, a specialized apheresis technique, in treating peripheral artery disease with limb-threatening ischemia in patients undergoing hemodialysis. The study aims to address the limitations of conservative treatments for patients with end-stage renal disease who have not responded to traditional revascularization methods. By reducing plasma viscosity and eliminating inflammatory mediators, rheopheresis may improve microcirculation and overall limb health. The trial will involve both active rheopheresis and a sham procedure to assess the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with end-stage renal disease on hemodialysis and severe peripheral artery disease with tissue loss or ulcers.
Not a fit: Patients who require immediate revascularization procedures or are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve limb health and quality of life for hemodialysis patients suffering from severe peripheral artery disease.
How similar studies have performed: Previous studies have shown the effectiveness of rheopheresis in treating other microcirculatory disorders, but its application in peripheral artery disease is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or more * End stage renal disease (ESRD) treated by hemodialysis or hemodiafiltration * PAD-LTI with tissue loss and/or wounds (ulcers or gangrene) with at least one of the following criterion: arterial pressure assessment at the ankle \<70 millimeter of mercury (mmHg), or toe pressure 30 mmHg, or transcutaneous oximetry measurements \< 40 mmHg * Interventional or surgical revascularization either not technically possible or no necessary. Or if revascularization has already been performed and the diagnosis of chronic critical ischemia is maintained. * Female of childbearing potential, will have to use highly effective methods of contraception from study start to the end. * Medical insurance * Signed informed consent Exclusion Criteria: * Need for revascularization either endovascular (angioplasty) or surgery (bypass) of the ischemic lesion area * Pregnancy or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without contentment, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations * Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy) * Life expectancy greater than 1 year * Severe cognitive or psychiatric disorders * History of allergic reaction to dialysis membrane * Patients unable to give an informed consent or unwilling to participate in the study
Where this trial is running
Marseille
- Assistance Publique Hôpitaux de Marseille — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Thomas ROBERT, PH
- Email: thomas.robert@ap-hm.fr
- Phone: 491384095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.