Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

June 16, 2021 updated by: University of Zurich

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

Completed

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

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • ZH
      • Zurich, ZH, Switzerland, CH-8091
        • Department of Dermatology, University Hospital of Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • Martorell HYTILU (A1)
  • Calciphylaxis (calcific uremic arteriolopathy)(A2)
  • Venous ulcers (as control group)(B)
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:

  • Martorell HYTILU (A1)
  • Calciphylaxis (calcfic uremic arteriolopathy) (A2)
  • Venous ulcers (control group) (B)
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

April 13, 2012

First Posted (Estimate)

April 16, 2012

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

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.

Clinical Trials on Calciphylaxis

3
Subscribe