Clinical trial to evaluate efficacy and safety of apheresis therapy on peripheral arterial disease with critical limb ischemia.

Clinical trial to evaluate efficacy and safety of apheresis therapy on peripheral arterial disease with critical limb ischemia. - Clinical trial of apheresis therapy on peripheral arterial disease (ASK-005).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020336

Enrollment

Registered

2015-12-25

Start date

2015-08-27

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Peripheral arterial disease

Interventions

Apheresis therapy Single treatment is up to 2 hours. Twice a week, up to 24 treatments (for 12 weeks).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients 20 to 85 years of age 2. Patients above 45 kg body weight 3. Patients with ischemic ulcer below lisfranc joint 4. Patients with SPP 20 to 50 mmHg at dorsal or planter of foot with ischemic ulcer 5. Patients who are no option for revascularization as determined by an independent third party vascular specialist

Exclusion criteria

Exclusion criteria: 1. Patients below SPP 20 mmHg at dorsal or planter of foot with ischemic ulcer 2. Patients with ischemic ulcer above ankle joint 3. Patients with metatarsal osteomyelitis 4. Patients planned to undergo major amputation of any lower limb above lisfranc joint 5. Patients who are unable to refrain from angiotensin converting enzyme inhibitor

Design outcomes

Primary

Measure	Time frame
Rate of completely healed ischemic ulcer upon to 24 weeks after apheresis therapy	—

Secondary

Measure	Time frame
1. Time to complete ischemic ulcer healing 2. Granulation formation in ischemic ulcer 3. Changes in skin perfusion pressure at the foot with ischemic ulcer 4. Changes in ankle brachial index 5. Analysis of adverse events	—

Countries

Japan

Contacts

Public ContactMasaji Kawatsu

Kaneka Corporation Medical Devices Solutions Vehicle

Masaji.Kawatsu@kaneka.co.jp080-2408-0766

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026