Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

NCT01578382 | Completed

• 1 other identifier: KEK-ZH-NR2010-0433/0
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Ischemic Leg Ulcer; Calciphylaxis

Keywords

Martorell hypertensive ischemic leg ulcer; Calciphylaxis (calcific uremic arteriolopathy); Ischemic subcutaneous arteriolosclerosis; Hypertension; Diabetes; Medial calcinosis; Wound healing

Outcome Measures

Primary Outcomes (1)

• Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification

  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 Outcomes (1)

• Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation

  36 months

Study Arms (3)

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

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Dermatology, University Hospital of Zurich

Zurich, Canton of Zurich, CH-8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

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)

MeSH Terms

Conditions

Calciphylaxis; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Jürg Hafner, Professor

  Department of Dermatology, University Hospital of Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: April 16, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

CH (1)