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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

May 2, 2011
December 1, 2015
September 2011
December 2018   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01578382 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)
Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU): A Comparison of Martorell HYTILU, Calciphylaxis and Venous Ulcer (Control)

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.

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)

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
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)
Probability Sample
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)
  • Hypertensive Ischemic Leg Ulcer
  • Calciphylaxis
Not Provided
  • 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

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2018
December 2018   (final data collection date for primary outcome measure)

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:

Both
20 Years to 90 Years   (Adult, Senior)
No
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
Switzerland
 
NCT01578382
KEK-ZH-NR2010-0433/0
No
Not Provided
Not Provided
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Jürg Hafner, Professor Department of Dermatology, University Hospital of Zurich, Switzerland
University of Zurich
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP