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
|
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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 |
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 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 |

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 |
- 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)
- 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

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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 |
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:

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
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 | |
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 |
Principal Investigator: | Jürg Hafner, Professor | Department of Dermatology, University Hospital of Zurich, Switzerland |
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 |