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Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Hypertensive Ischemic Leg Ulcer
Calciphylaxis

Study type

Observational

Funder types

Other

Identifiers

NCT01578382
KEK-ZH-NR2010-0433/0

Details and patient eligibility

About

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.

Full description

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)

Enrollment

120 patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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