Pathophysiological study on xerosis, disorders of vascular/blood flow and neuropathy in diabetic patients

JRCT ID: jRCT1030220103

Registered date:31/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetes Mellitus
• Date of first enrollment: 10/06/2022
• Target sample size: 30
• Study type: Observational

Outcome(s)

• Primary Outcome: Trans epidermal water loss, stratum corneum hydration, overall dry skin score, pruritus NRS, blood flow, capillary formation, current perception threshold, adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 60age old
• Gender: Male

Include criteria

1) Group with diabetes mellitus
1. Male outpatients with Type 2 diabetes mellitus
2. Patients who can give voluntary written consent to participate in the present study.

2) Control group (Group without diabetes mellitus)
1. adult male
2. Persons who can give voluntary written consent to participate in the present study.

Exclude criteria

1) Group with diabetes mellitus
1. Patients who have/had diseases which may cause peripheral neuropathy.
2. Patients who have /had diseases which may cause xerosis excluding due to physiological and environmental factors.
3. Patients with skin diseases excluding xerosis at the measurement sites
4. Patients with diabetic foot gangrene or foot ulcer.
5. Patients who are taking drugs for neuropathic pain.
6. Patients with mental disease
7. Patients who are being treated with peripheral vasodilation drugs.
8. Patients who routinely use emollient/moisturizer at the measurement sites.
9. Patients who are considered to be unsuitable for the study by the investigator.

2) Control group (Group without diabetes mellitus)
1. Persons who have/had diseases which may cause peripheral neuropathy.
2. Persons who have /had diseases which may cause xerosis.

3. Persons with skin diseases excluding xerosis at the measurement sites
4. Persons who are taking drugs for more than 28 days.
5. Persons who routinely use emollient/moisturizer at the measurement sites.
6. Persons who are considered to be unsuitable for the study by the investigator.

Related Information

• Primary Sponsor: Noto Hiroshi
• Source(s) of Monetary Support: Maruho Co., Ltd.