Diabetic skin ulcer, Leg ulcer
Conditions
Interventions
SR-0379(0.02%) is sprayed to skin ulcer once per day for 28 days.
SR-0379(0.1%) is sprayed to skin ulcer once per day for 28 days.
SR-0379(0.5%) is sprayed to skin ulcer once per day for 28 days.
Plac
Sponsors
Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 20 years old 2. Diabetic skin ulcer or leg ulcer (arterial or venous ulcer) 3. Less than 6 cm diameter of skin ulcer
Exclusion criteria
Exclusion criteria: 1. infection to be cured with antibiotics 2. Deep ulcer with reaching bone 3. Ulcer due to malignant tumor 4. Severe edema around skin ulcer 5. patients with malignant tumor 6. patients with severe heart failure 7. patients with severe liver, kidner and blood dyufunction 8. worse nutrition status(less than 2 g/dL in serum albumin) 9. worse body status due to severe infection 10. poor control of diabetes (more than 9.0% in HbA1c) 11. Pregnant women, men or women in disagree with birth control during clinical trial period 12. Start or change of drug usage for vasodilators from 2 weeks before SR-0379 or placebo treatment 13. Surgical procedure for skin ulcer from 2 weeks before SR-0379 or placebo treatment 14. Attendance to other clinical trial from 12 weeks before SR-0379 or placebo treatment 15. Judge as an inappropriate patient by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer size at 4 weeks after treatment | — |
Countries
Japan
Contacts
Public ContactHironori Nakagami
Osaka University Health Development and Medicine
Outcome results
None listed