Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2019-12-31

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.

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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)

Conditions

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Hypertensive Ischemic Leg Ulcer Calciphylaxis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypertensive ischemic leg ulcer

Twenty consecutive patients with Martorell HYTILU as defined in:

Arch Dermatol 2010;146:961-968

No interventions assigned to this group

Calciphylaxis

Ten subjects with calciphylaxis (calcific uremic arteriolopathy) as described in:

Vasa 1998;27:137-143

No interventions assigned to this group

Venous ulcer (controls)

Twenty subjects with venous ulcers (CEAP C4-6) as described in:

J Vasc Surg. 2004 Dec;40(6):1248-52

No interventions assigned to this group

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)