Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01578382

Enrollment

120

Registered

2012-04-16

Start date

2011-09-30

Completion date

2019-12-31

Last updated

2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calciphylaxis, Hypertensive Ischemic Leg Ulcer

Keywords

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

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)

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Switzerland

Outcome results