Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU): A Comparison of Martorell HYTILU, Calciphylaxis and Venous Ulcer (Control)

Conditions
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Hypertensive Ischemic Leg Ulcer, Calciphylaxis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypertensive ischemic leg ulcer<br>Twenty consecutive patients with Martorell HYTILU as defined in: Arch Dermatol 2010;146:961-968 | |
| Calciphylaxis<br>Ten subjects with calciphylaxis (calcific uremic arteriolopathy) as described in: Vasa 1998;27:137-143 | |
| Venous ulcer (controls)<br>Twenty subjects with venous ulcers (CEAP C4-6) as described in: J Vasc Surg. 2004 Dec;40(6):1248-52 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Martorell hypertensive ischemic leg ulcer, Calciphylaxis (calcific uremic arteriolopathy), Ischemic subcutaneous arteriolosclerosis, Hypertension, Diabetes, Medial calcinosis, Wound healing