Cutaneous ulcer (pressure ulcer, diabetic ulcer)
Conditions
Interventions
investigational material(s)
Generic name etc : SR-0379
INN of investigational material : -
Therapeutic category code : 269 Other agents for epidermis
Dosage and Administration for Investigational mate
Sponsors
Shionogi & Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients whose major axis of ulcer is 1 cm or more and 6 cm or less, and depth of ulcer is classified into d2, D3, or D4 referring to the DESIGN-R(R) for evaluation of pressure ulcer (Japanese Society of Pressure Ulcers), etc.
Exclusion criteria
Exclusion criteria: Patients who have ulcer with apparent infection including flare, swelling, pus, malodor, or fever around the ulcer, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The percent reduction in surface area of the ulcer | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Percentage of patients with any adverse events, etc. | — |
Countries
Japan
Outcome results
None listed