Clinical study on physiological indicators of pain in patients with foot ulcers

JRCT ID: jRCT1052210078

Registered date:05/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Foot ulcer
• Date of first enrollment: 05/09/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Thrmal stimulation
The experimental thermal stimuli of 30 degrees to 50 degrees are applied to the forearm of the research subject using the thermal stimulator.

Ischemic condition
The ischemic condition is induced by the exercise such as bending and
stretching of the fingers or ankle of the research subject,
with the bag-shaped belt for blood pressure measurement wrapped and inflated
around the upper arm or thigh.

Outcome(s)

Primary Outcome

Electroencephalogram-based pain scores, Numerical Rating Scale,
Visual Analogue Scale, Current value from Pain Vision
Value of SFMPQ-2

• Secondary Outcome: Pulse rate, Pulse wave amplitude, Skin conductance response

Key inclusion & exclusion criteria

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

Include criteria

1.Patients who were diagnosed with foot ulcer
2.Age: patients over 20 at the time of acquiring consent
3.Gender: male and female
4.Patients who have consented to particpate in this study after receiving sufficient explanation for this study and gained sufficient understandings

• Exclude criteria: A patient who was judged as inappropriate as a research subject by the research director

Related Information

• Primary Sponsor: Kunihiro Nakai
• Secondary Sponsor: PaMeLa Inc.