Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

Calciphylaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578382
• Other study ID #: KEK-ZH-NR2010-0433/0
• Status: Completed
• Start date: September 2011
• Est. completion date: December 2019

Study information

• Verified date: June 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Calciphylaxis
• Hypertensive Ischemic Leg Ulcer
• Ischemia
• Leg Ulcer
• Ulcer

Locations

Country	Name	City	State
Switzerland	Department of Dermatology, University Hospital of Zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation	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