Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU): A Comparison of Martorell HYTILU, Calciphylaxis and Venous Ulcer (Control)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
结局指标
主要结局
Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification
时间窗: 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)
次要结局
- Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation(36 months)