jRCT1032230294招募中不适用
Comprehensive analysis-driven identification of mechanisms and biomarkers of therapeutic apheresis to cure ulcer in peripheral arterial disease study (CURE-PAD study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 主要终点
- Changes in the scores of the ulcer before and after apheresis therapy
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Part 1: Patients who meets all of the criteria lisited below:
- •Patients who were diagnosed with arteriosclerosis obliterans.
- •Patients with lower limb lesion of Fontaine classification IV (ulcers and/or gangrene).
- •Patients who has lesions refractory to conventional pharmacotherapies and are unable or difficult to undergo revascularization by percutaneous transluminal angioplasty (PTA) or vascular surgery according to the attached document and/or practical guide of Rheocarna.
- •Patients who can provide written informed consent. If the patients are not able to provide informed consent, the representative can provide written informed consent.
- •Patients who had participated in the LDL Apheresis-Mediated Endothelial Activation Therapy to Severe Peripheral Artery Disease (LETS-PAD) study (jRCTs032180100) and had lower limb lesions of Fontaine classification IV (ulcers and/or gangrene) and gave permission for secondary use of samples and information.
排除标准
- •Part 1: Patients who meets all of the criteria lisited below:
- •Patients who undergo any of the therapies listed below during the aferesis sessions:
- •a) Any other apheresis therapies (regardless of reasons)
- •Patients whose doctor diagnosed that apheresis therapy is not indicated according to the attached document and/or practical guide of Rheocarna.
- •Patients who denied permission for secondary use of samples and information.
结局指标
主要结局
Changes in the scores of the ulcer before and after apheresis therapy
The size, severity of inflammatory/infectious lesions, proportions of granulation tissue, and severity of necrotic lesions of the ulcer are evaluated according to DESIGN-R. One ulcer is chosen for assessment of therapeutic effects.
Changes in proteins and metabolites in blood samples before and after apheresis therapy
Proteomic (and metabolomic analyses in Part 2) are conducted on blood samples to measure proteins and metabolites comprehensively. Changes in the measurements of each biomarker before and after apheresis therapy are calculated.
次要结局
未报告次要终点
研究者
相似试验
招募中
Unknown
Comprehensive analysis-driven identification of mechanisms and biomarkers of therapeutic apheresis to cure ulcer in peripheral arterial disease studyPeripheral arterial diseaseArteriosclerosis obliteransPeripheral arterial diseaseArteriosclerosis obliteransJPRN-jRCT1032230294Wakui Hiromichi10
进行中（未招募）
1 期
Development of an algorithm for identification of responders to short term treatment with esomeprazol (Nexium) in primary care. - PPI Response Trialacid related diseaseEUCTR2006-000574-69-DKAstraZeneca A/S
招募中
不适用
Breakdown, Identification and Observation of the microenvironment of acute and chronic woundsacute woundschronic woundsDRKS00017390Institut für Translationale Wundforschung, Zentrum für biomedizinische Ausbildung und Forschung (ZBAF), Universität Witten/Herdecke160
尚未招募
3 期
Development of the method for the identification of treatment resistance using hypoxia PETJPRN-UMIN000029884kyushu University100
已完成
不适用
Data collection for development of a software program to detect pulmonary TB from chest X-RaysCTRI/2017/09/009722Philips India Limited400