An observational study in Hypertensive Ischemic Leg Ulcer and Calciphylaxis, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by University of Zurich · Observational
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
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)
23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.
This study's enrollment of 120 is below the median of 450 across 10 observational studies indexed under Calciphylaxis.
Browse Calciphylaxis studies →University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
n=20: Having Martorell hypertensive ischemic leg ulcer (as defined above) or n=10: Having Calciphylaxis (calcific uremic arteriolopathy (as defined above) or n=20: Having a venous ulcer (as defined above) (controls)
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Exclusion Criteria:
Twenty consecutive patients with Martorell HYTILU as defined in: Arch Dermatol 2010;146:961-968
Ten subjects with calciphylaxis (calcific uremic arteriolopathy) as described in: Vasa 1998;27:137-143
Twenty subjects with venous ulcers (CEAP C4-6) as described in: J Vasc Surg. 2004 Dec;40(6):1248-52
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
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
The record gives a start of Sep 2011, a primary completion of Dec 2019 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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