UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028750
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

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Basic information

Public title

Treatment with a novel peptide, SR-0379, for the Werner syndrome patients with limb ulcers

Acronym

Treatment with a novel peptide, SR-0379, for the Werner syndrome patients with limb ulcers

Scientific Title

Treatment with a novel peptide, SR-0379, for the Werner syndrome patients with limb ulcers

Scientific Title:Acronym

Treatment with a novel peptide, SR-0379, for the Werner syndrome patients with limb ulcers

Region

Japan


Condition

Condition

leg ulcers with diabetes or critical limb ischemia or Werner syndrome

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

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.

Key secondary outcomes

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.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

SR-0379(0.1%) is sprayed to skin ulcer once per day for 28 days.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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

Key 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

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironori Nakagami

Organization

Osaka University Graduate School of Medicine

Division name

Department of Health Development and Medicine

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6210-8359

Email

nakagami@gts.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironori Nakagami

Organization

Osaka University Graduate School of Medicine

Division name

Department of Health Development and Medicine

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6210-8359

Homepage URL


Email

nakagami@gts.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

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)


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 04 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

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.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 07 Month 18 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 20 Day

Last modified on

2018 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032842


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name