Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertensive Ischemic Leg Ulcer Calcinosis Calciphylaxis Calcium Metabolism Disorders Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology, University Hospital of Zurich

Zurich, Canton of Zurich, CH-8091, Switzerland

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU): A Comparison of Martorell HYTILU, Calciphylaxis and Venous Ulcer (Control)

Important dates

Study start: 2011
Primary completion: 2019
Study completion: 2019
First posted: Apr 16, 2012
Registry last updated: Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed