An exploratory clinical study on intermittent negative pressure chamber system in patients with critical limb ischemia

JRCT ID: jRCTs022210062

Registered date:05/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Critical limb ischemia
• Date of first enrollment: 23/03/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Use of intermittent negative pressure chamber system device (FlowOx), not approved in Japan

Outcome(s)

• Primary Outcome: Adverse events

Secondary Outcome

1) Defect
2) MALE(Major Adverse Limb Event),Amputation Free Survival Death rate,Targeted wound recurrence rate

Key inclusion & exclusion criteria

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

Include criteria

1) Patients who are 20 years of age or older
2) Patients who have given written consent to participate in the study.
3) Patients with wounds more peripheral than the foot (including lateral and medial malleolus),have diagnosed with ischemia during the standard treatment, have failed to heal for 4 weeks, and have wounds that are greater than 5.0 mm but less than 12.0 cm in length by visual assessment
4) Patients with peripheral arterial disease for whom revascularization is not adapted with a Rutherford classification of 5 or higher as the following
Patients for whom revascularization cannot be performed
Patients who have performed a revascularization but have not improved their wounds due to failure or restenosis
5) Patients who are able to use FlowOx appropriately

Exclude criteria

1)Patients who have performed ascheduled for revascularization or amputation during the study period
2) Patients who have performed a revascularization within 30 days
3) Patients who have received cell therapy, gene therapy, or polyplatelet plasma therapy (PRP therapy)
within 30 days.
4) Patients who have received LDL apheresis, hyperbaric oxygen therapy (HBOT), or local negative pressure closure therapy (NPWT) within 3 days.
5)Patients with osteomyelitis extending from the metatarsals to the distal phalanges
6) Patients with severe soft tissue infection
7) Patients in whom the popliteal artery of the target limb is not palpable
8) Patients with amputation of the contralateral lower leg or thigh
9)Patients with a tendency for the wound to enlarge compared to the start of standard treatment
10) Patients with acute limb ischemia
11) Patients with deep vein thrombosis, pulmonary embolism, uncontrolled infection, malignancy, cerebral infarction, or serious cardiac disease
12) Patients who are pregnant or planning to become pregnant during the study period
13) Patients who are judged by the principal investigator or sub-investigator to be inappropriate for participation in this study.

Related Information

• Primary Sponsor: Ohura Norihiko
• Source(s) of Monetary Support: TEIJIN PHARMA LIMITED.
• Secondary ID(s): Nil known