leg ulcers with diabetes or critical limb ischemia or Werner syndrome
Conditions
Interventions
SR-0379(0.1%) is sprayed to skin ulcer once per day for 28 days.
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. More than 1 cm or 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, kidney and blood dysfunction (excluding stable dialysis patient) 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 |
|---|---|
| Peptide efficiency was evaluated by determining the rate of wound size reduction as a primary endpoint at 4 weeks after the first treatment compared with the pretreatment wound size. | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary endpoint, the 50% wound size reduction ratio, the DESIGN-R score index, time to wound closure and quantitative analysis of bacterial culture in wound were evaluated. | — |
Countries
Japan
Contacts
Public ContactHironori Nakagami
Osaka University Graduate School of Medicine Department of Health Development and Medicine
Outcome results
None listed