Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT01578382

Collaborator

(none)

120

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertensive Ischemic Leg Ulcer Calciphylaxis

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 Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

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)