The investigators propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis in the hemodialysis population.
Calciphylaxis, also known as uremic calcifying arteriolopathy (UCA), is a rare disease that causes painful ischemic skin lesions due to microvascular calcification and thrombosis of the dermis and subcutaneous adipose tissue. Patients with end-stage renal disease (ESRD) are the main target for calciphylaxis. Rheopheresis is a therapeutic apheresis to treat microcirculatory disorders. This double filtration plasmapheresis eliminates a defined spectrum of high molecular weight proteins from human plasma including relevant factors for vascular inflammation and thrombose. The investigators propose a prospective randomized controlled trial to compared the efficacy of rheopheresis as adjuvant treatment to the standard of care compared to standard care with Sham-apheresis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
138
rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
Sham-apheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient.
Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions).
Complete wound healing is defined as the absence of livedoid peri-lesional inflammation with presence of granulation tissue (stage 3 healing process) and/or epithelization (stage 4) over the entire ulcer surface of calciphylactic lesions. The healing of the lesions will be illustrated with a photographic support. And the pictures will be examined a second time in a centralized and blind way by two referring dermatologists. In case of multiple calciphylaxis skin lesions, monitoring and evaluation will be done on the largest lesion at the time of patient's inclusion.
Time frame: at 12 weeks of treatement
Percentage of patient with partial wound healing of the calciphylaxis mediated lesions after rheopheresis treatment.
The partial healing is defined by a partial reepithelialization (validated if 3 of following 4 criteria are present: 1-absence of necrosis; 2- granulation; 3 less inflammatory bordering 4- 20% decrease of the lesion size). The evolution of the size of the lesions and the partial healing of the wound will be illustrated by a photographic support.
Time frame: At 4 weeks and 12 weeks of rheopheresis treatment.
Occurrence of new ulcerated calciphylaxis lesions
Occurrence of new ulcerated calciphyalxis lesions frome Baseline to 4 and 12 weeks of treatment.
Time frame: At 4 weeks and 12 weeks of rheopheresis treatment.
Evolution of the self-reporting pain using Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) describes the pain intensity at 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme
Time frame: from baseline (V0) to 12 weeks of rheopheresis (V2)
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Evolution of the level of antalgic consumed according to World Health Organisation (WHO) classification
The level of consumed antalgic is defined according to the World Health Organization (WHO) classification * Level I analgesics = peripheral analgesics or not morphine have the lowest analgesic power * Level II analgesics = weak morphine. * Level III analgesics = strong morphine agonists and antagonists.
Time frame: from baseline (V0) to 12 weeks of rheopheresis (V2)
Number of days without antibiotics
Number of days the patient receives antibiotics, regardless of the route of administration, whether the patient is treated on an outpatient or inpatient basis.
Time frame: during the 12 weeks of rheopheresis treatment
Quality of life by the Wound quality of life score (Wound-Qol)
The Wound-QoL measures the disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which are always assessed in retrospect to the preceding seven days.
Time frame: form baseline (V0) and at 12 weeks
Number of days discharged from hospital
Number of days the patient is treated on an outpatient basis.
Time frame: during the 12 weeks of rheopheresis treatment
Overall survival
Survival of patients, whether or not calciphylaxis is cured.
Time frame: at 12 weeks and 12 months after first rheopheresis.
Change in inflammatory proteins
Change in the plasmatic rates of C-reactive protein (CRP) and fibrinogen.
Time frame: from baseline to 12 weeks-rheopheresis treatment