Developing a foot-care device using nano-bubble water

JRCT ID: jRCTs042240031

Registered date:23/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Lime-Threating Ischemia
• Date of first enrollment: 23/05/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Washing foot with oxygen nano-bubble instead of conventional water or normal saline

Outcome(s)

• Primary Outcome: rate of wound reduction
• Secondary Outcome: level of white blood cell count, C-reactive protein and procalcitonin in blood tests

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. A patint who consented to this study after adequate explanation
2. A patient whose age is between 20 and 85.
3. A patient suffered from a refractory ulcer for more than 2 weeks
4. A patient whose lesion is graded as 5 in Rutherford Staging

Exclude criteria

1. A patient who could not walk at all
2. A patient who could not understand the aim of this study because of dementia or psychotic disease
3. A patient suffered from a severe dermatic disease
4. A patient judged as inappropriate by Principal Investigator or Subinvestigators.
5. A patient who might undergo a major amputation or revascularization for the lower limb

Related Information

• Primary Sponsor: Yamanouchi Dai