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Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01578382
First received: May 2, 2011
Last updated: December 1, 2015
Last verified: December 2015
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: December 2018
Estimated Primary Completion Date: December 2018 (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   (Adult, Senior)
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: December 1, 2015
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:
Ischemia
Ulcer
Leg Ulcer
Calciphylaxis
Skin Ulcer
 Pathologic Processes
Skin Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2016