Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

University of Zurich120 enrolled

Overview

Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction) which occurs in long-term hypertensive subjects. Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin infarction) which occurs in subjects with end-stage kidney disease or after kidney transplantation.

Comparative study including * 20 consecutive patients with Martorell HYTILU * 10 consecutive patients with Calciphylaxis (calcific uremic arteriolopathy) * 20 patients with venous ulcer The following parameters are measured in the blood serum: White blood count; c-reactive protein; creatinine; calcium (total); free (ionized) calcium; phosphate; albumin; 25-hydroxyvitamin-D; 1-25-dihydroxyvitamin-D; homocysteine; cystatin C alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1) The following parameters are measured in samples of diseased (necrobiotic) skin: alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Hypertensive Ischemic Leg Ulcer Calciphylaxis

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Having Martorell hypertensive ischemic leg ulcer (as defined above) or * Having Calciphylaxis (calcific uremic arteriolopathy (as defined above) or * Having a venous ulcer (as defined above) Exclusion Criteria: * None

Locations (1)

Department of Dermatology, University Hospital of Zurich

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification

Comparison of the calcification-protective factors GLA-1(serum protein alpha2-Heremans-Schmid glycoprotein/fetuin A), Osteoprotegerin, Fibroblast Growth Factor 23, and Alphafetoin in: * Martorell HYTILU (A1) * Calciphylaxis (calcific uremic arteriolopathy)(A2) * Venous ulcers (as control group)(B)

Time frame: 36 months

Secondary Outcomes

Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation

Comparison of C-reactive protein, procalcitonin and white blood cell count in: * Martorell HYTILU (A1) * Calciphylaxis (calcfic uremic arteriolopathy) (A2) * Venous ulcers (control group) (B)

Time frame: 36 months

Data from ClinicalTrials.gov

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