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Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

This study is currently recruiting participants.
Verified April 2011 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01578382
First received: May 2, 2011
Last updated: April 13, 2012
Last verified: April 2011
History of Changes
  Purpose

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
Hypertensive Ischemic Leg Ulcer
Calciphylaxis

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    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:
  • Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    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)


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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)

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01578382     History of Changes
Other Study ID Numbers: KEK-ZH-NR2010-0433/0
Study First Received: May 2, 2011
Last Updated: April 13, 2012
Health Authority: Switzerland: Ethikkommission

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:
Calciphylaxis
Ischemia
Leg Ulcer
Ulcer
Skin Ulcer
 Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013