JRCT ID: jRCT2031210266
Registered date:20/08/2021
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of SR-0379 in Participants with Skin Ulcer
Basic Information
| Recruitment status | Not Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | skin ulcer |
| Date of first enrollment | 02/08/2021 |
| Target sample size | 120 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | SR-0379 or placebo spray |
Outcome(s)
| Primary Outcome | The days to simple surgical intervention (ncluding suturing, grafts or flaps) |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | < 85age old |
| Gender | Both |
| Include criteria | Patients must have a wound requiring wound bed preparation in advance of planned surgical closure (including suturing, grafts or flaps) |
| Exclude criteria | Presence of untreated ulcer infection (redness, swelling, pus, foul odor, fever) |
Related Information
| Primary Sponsor | Ichioka Shigeru |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Hideki Tomioka |
| Address | Office for University-Industry Collaboration Bldg. A, 5F No.509, Osaka University 2-1 Yamadaoka, Suita, Osaka Osaka Japan 565-0871 |
| Telephone | +81-6-6369-7957 |
| htomioka@funpep.co.jp | |
| Affiliation | FunPep Co., Ltd. |
| Scientific contact | |
| Name | Shigeru Ichioka |
| Address | 38 Morohongo Moroyama-machi, Iruma-gun Saitama Japan 350-0451 |
| Telephone | +81-492-76-1299 |
| ichioka2006@yahoo.co.jp | |
| Affiliation | Saitama Medical University Hospital |