Combined Treatment with Hyperbaric Oxygen Therapy and Endovascular therapy FOr Patients with ChrOnic Limb-Threatening Ischemia

Combined Treatment with Hyperbaric Oxygen Therapy and Endovascular therapy FOr Patients with ChrOnic Limb-Threatening Ischemia -Multicenter Randomized Controlled Trial- - HOTFOOT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042839

Enrollment

140

Registered

2021-01-01

Start date

2021-02-01

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

Chronic limb-threatening ischemia Arteriosclerosis obliterans

Interventions

Patients received combined treatment with hyperbaric oxygen therapy(HBOT) and endovascular treatment (Combined treatment group) A session of HBOT was performed with a chamber pressurized at 2.0 to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic limb-threatening ischemia having 1. toe pressure <30 mm Hg, or SPP <30 mm Hg or TcPO2 <30 mm Hg 2. ischemic ulcer or gangrene, namely Fontaine stage IV, Rutherford classification 5 or 6 3. primary success in endovascular treatment.

Exclusion criteria

Exclusion criteria: 1. Patients during pregnancy or breastfeeding 2. Contraindicated patients with hyperbaric oxygen therapy 3. Patients scheduled to undergo LDL apheresis 4. Patients with severe infection (namely, foot infection grade 3 in the Wound, Ischemia, and foot Infection [WIfI] classification)

Design outcomes

Primary

Measure	Time frame
Time to wound healing in 6 months	—

Secondary

Measure	Time frame
1.Wound healing rate at 6 months 2.Major lower limb amputation rate at 6 months 3.Amputation free survival at 6 months 4.The rate of re-intervention at 6 months	—

Countries

Japan

Contacts

Public ContactYusuke Sato

Tokeidai memorial hospital Cardiovascular center

toppy1363@gmail.com0112511221

Outcome results

None listed

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