A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum
1 other identifier
interventional
56
0 countries
N/A
Brief Summary
56 patients with scleredema diabeticorum will be selected to receive treatment of tranilast. After a period of time ,we can determine the efficacy of the drug by detecting the the thickness of skin before and after treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jun 2018
Typical duration for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2018
CompletedFirst Posted
Study publicly available on registry
May 1, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 1, 2018
January 1, 2018
2 years
April 19, 2018
April 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure the volume change of skin lesions by ultrasound
During tranilast (0.1g each time, three times a day, 6 months) treatment, patients need to test lesion volume.The reduction of volume greater than 50% is judged to be effective
This experiment will last for 6 months
Study Arms (1)
Tranilast
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- (1)Clinical and histopathological examination has been proved to be scleredema diabeticorum; (2)Ultrasound and magnetic resonance detection found that the thickest skin of the back was more than 5mm.
You may not qualify if:
- (1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)Poor blood sugar control; (3)with mental disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2018
First Posted
May 1, 2018
Study Start
June 1, 2018
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
May 1, 2018
Record last verified: 2018-01