- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01578382
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.
Study Overview
Status
Conditions
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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
ZH
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Zurich, ZH, Switzerland, CH-8091
- Department of Dermatology, University Hospital of Zürich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jürg Hafner, Professor, Department of Dermatology, University Hospital of Zurich, Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-NR2010-0433/0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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