Unique ID issued by UMIN | UMIN000028750 |
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Receipt number | R000032842 |
Scientific Title | Treatment with a novel peptide, SR-0379, for the Werner syndrome patients with limb ulcers |
Date of disclosure of the study information | 2017/09/04 |
Last modified on | 2018/05/22 10:11:11 |
Treatment with a novel peptide, SR-0379, for the Werner syndrome patients with limb ulcers
Treatment with a novel peptide, SR-0379, for the Werner syndrome patients with limb ulcers
Treatment with a novel peptide, SR-0379, for the Werner syndrome patients with limb ulcers
Treatment with a novel peptide, SR-0379, for the Werner syndrome patients with limb ulcers
Japan |
leg ulcers with diabetes or critical limb ischemia or Werner syndrome
Dermatology |
Others
NO
To evaluate the safety and efficacy of SR-0379 for the treatment of leg ulcers with diabetes or critical limb ischemia or Werner syndrome, a physician-initiated, phase IIa, clinical study was conducted.
Safety,Efficacy
Exploratory
Phase II
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.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
SR-0379(0.1%) is sprayed to skin ulcer once per day for 28 days.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
6
1st name | |
Middle name | |
Last name | Hironori Nakagami |
Osaka University Graduate School of Medicine
Department of Health Development and Medicine
2-2 Yamadaoka, Suita, Osaka
06-6210-8359
nakagami@gts.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Hironori Nakagami |
Osaka University Graduate School of Medicine
Department of Health Development and Medicine
2-2 Yamadaoka, Suita, Osaka
06-6210-8359
nakagami@gts.med.osaka-u.ac.jp
Osaka University
AMED
Japanese Governmental office
NO
大阪大学医学部附属病院(大阪府)、千葉大学医学部附属病院(千葉県)、春日部中央総合病院(埼玉県)
2017 | Year | 09 | Month | 04 | Day |
Unpublished
The reduction rate of the skin ulcer at the last evaluation (4th week or discontinued point), the primary endpoint, were 22.90% for skin ulcer with Werner syndrome (n=4) and 35.70% for Diabetic ulcer (n=4). In the evaluation of DESIGN-R score index, one of the secondary endpoints, were also decreased in both group (from 8.8 to 4.8 in Werner syndrome patients, from 8.0 to 3.8 in Diabetic ulcer). Two adverse events were observed in 2 subjects, which had no causal relationships with SR-0379 treatment.
Completed
2017 | Year | 07 | Month | 18 | Day |
2017 | Year | 09 | Month | 04 | Day |
2017 | Year | 08 | Month | 20 | Day |
2018 | Year | 05 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032842
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