Comprehensive analysis-driven identification of mechanisms and biomarkers of therapeutic apheresis to cure ulcer in peripheral arterial disease study - CURE-PAD study

Wakui Hiromichi0 个研究点目标入组 10 人开始时间: 2023年8月18日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Part 1: Patients who meets all of the criteria lisited below:
•1) Patients who were diagnosed with arteriosclerosis obliterans.
•2) Patients with lower limb lesion of Fontaine classification IV (ulcers and/or gangrene).
•3) 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.
•4) 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.

•Part 1: Patients who meets all of the criteria lisited below:
•1) Patients who undergo any of the therapies listed below during the aferesis sessions:
•a) Any other apheresis therapies (regardless of reasons)
•b) Negative pressure wound therapy
•c) Hyperbaric oxygen therapy
•2) Patients who undergoes glucocorticoids or other imunosuppressants.
•3) Patients with malignancy that is not cured or complete remission.
•4) 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.

发起方

Wakui Hiromichi