Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

Completed

• Conditions: Hypertensive Ischemic Leg Ulcer; Calciphylaxis

• Registration Number: NCT01578382
• Lead Sponsor: University of Zurich

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.

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 Timeline

• Study First Submitted: 2011-05-02
• Study Start: 2011-09
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification	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 Outcome Measures

Name	Time	Method
Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation	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)

Trial Locations

Locations (1)

Department of Dermatology, University Hospital of Zurich; 🇨🇭 Zurich, ZH, Switzerland