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Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

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ClinicalTrials.gov Identifier: NCT01578382
Recruitment Status : Recruiting
First Posted : April 16, 2012
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease
Hypertensive Ischemic Leg Ulcer Calciphylaxis

Detailed 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)


Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU): A Comparison of Martorell HYTILU, Calciphylaxis and Venous Ulcer (Control)
Study Start Date : September 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Hypertensive ischemic leg ulcer

Twenty consecutive patients with Martorell HYTILU as defined in:

Arch Dermatol 2010;146:961-968
Calciphylaxis

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

Vasa 1998;27:137-143
Venous ulcer (controls)

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification [ Time Frame: 36 months ]

    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)


Secondary Outcome Measures :
  1. Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation [ Time Frame: 36 months ]

    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)


Biospecimen Retention:   Samples With DNA
Blood serum (2 tubes); blood plasma in citrate (2 tubes); blood plasma in heparin (2 tubes) Diseased skin tissue in formalin for paraffin embedded H-E histology; Diseased skin tissue snap frozen Diseased skin tissue in "RNA later" tube (1 tube)

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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)
Criteria

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:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578382


Contacts
Contact: Jürg Hafner, Prof. MD +41 44 255 25 33 juerg.hafner@usz.ch
Contact: Lars E French, Prof. MD +41 44 255 25 50 lars.french@usz.ch

Locations
Switzerland
Department of Dermatology, University Hospital of Zurich Recruiting
Zurich, ZH, Switzerland, CH-8091
Contact: Jürg Hafner, Prof. MD    +41 44 255 25 33    juerg.hafner@usz.ch   
Contact: Lars E French, Prof. MD    +41 44 255 25 50    lars.french@usz.ch   
Principal Investigator: Jürg Hafner, Prof. MD         
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Jürg Hafner, Professor Department of Dermatology, University Hospital of Zurich, Switzerland
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01578382     History of Changes
Other Study ID Numbers: KEK-ZH-NR2010-0433/0
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

Keywords provided by University of Zurich:
Martorell hypertensive ischemic leg ulcer
Calciphylaxis (calcific uremic arteriolopathy)
Ischemic subcutaneous arteriolosclerosis
Hypertension
 Diabetes
Medial calcinosis
Wound healing

Additional relevant MeSH terms:
Ischemia
Ulcer
Leg Ulcer
Calciphylaxis
Skin Ulcer
 Pathologic Processes
Skin Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases