Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)

Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO) - Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016584

Enrollment

Registered

2015-02-20

Start date

2015-02-25

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 with wound and/or ulcer in the lower limb

Interventions

DF Thermo group (Patients underwent DF Thermo therapy) Study period

35 weeks at the maximum

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who fulfill all of the following conditions are included. 1) Age is over 20 years and less than 86 years, regardless of sex 2) Diagnosed as ASO with Fontaine Grade IV 3) With wound and/or ulcer in the lower limb and underwent bypass revascularization surgery 4) Patients who can give written informed consent by themselves or by their surrogates, understanding the objective and content of the study

Exclusion criteria

Exclusion criteria: Patients who fulfill any of the following conditions are excluded. 1) Pregnancy, breast-feeding, with possibility of pregnancy, or who wish to become pregnant during the study period 2) Patients who are considered as inadequate by the physician in charge

Design outcomes

Primary

Measure	Time frame
Rate of diminishment of wound and/or ulcer by DF thermo therapy	—

Secondary

Measure	Time frame
SPP, ABI, ultrasonography of lower limb, VEGF, fibrinogen, IgM, LDL-cholesterol, HDL-cholesterol, total cholesterol, DESIGN-R, Vascu QOL	—

Countries

Japan

Contacts

Public ContactShinji Togashi

Shonai Amarume Hospital Plastic and reconstructive surgery

stoga@amarume-hp.jp0234-43-3434

Outcome results

None listed

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