Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)
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| First Received Date ICMJE | May 2, 2011 | ||||||||
| Last Updated Date | April 13, 2012 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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:
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01578382 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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:
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU) | ||||||||
| Official Title ICMJE | Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU): A Comparison of Martorell HYTILU, Calciphylaxis and Venous Ulcer (Control) | ||||||||
| 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. |
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| Detailed Description | Comparative study including
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) |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | 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) |
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| 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) |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | April 2014 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01578382 | ||||||||
| Other Study ID Numbers ICMJE | KEK-ZH-NR2010-0433/0 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Zurich | ||||||||
| Study Sponsor ICMJE | University of Zurich | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||||||
| Verification Date | April 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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