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

JRCT ID: jRCT1032230294

Registered date:18/08/2023

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Peripheral arterial disease
Arteriosclerosis obliterans

• Date of first enrollment: 05/12/2022
• Target sample size: 6
• Study type: Observational

Outcome(s)

Primary Outcome

A. 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.
B. 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

• Secondary Outcome: Severity of lower limb ulcer before and after apheresis therapy and the rate of healing of ulcer.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Part 2:
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.

Exclude criteria

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)
2) Patients whose doctor diagnosed that apheresis therapy is not indicated according to the attached document and/or practical guide of Rheocarna.

Part2:
Patients who denied permission for secondary use of samples and information.

Related Information

• Primary Sponsor: Wakui Hiromichi
• Secondary Sponsor: Kaneka Corporation