A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03512873

Enrollment

Registered

2018-05-01

Start date

2018-06-30

Completion date

2020-12-31

Last updated

2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleredema Adultorum

Keywords

Scleredema Diabeticorum, Tranilast

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.

Detailed description

56 patients with Scleredema Diabeticorum will be selected. After the signing of the informed consent ,they will be collected the initial lesions photos,the thickness of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function.During tranilast (0.1g each time, three times a day,6 months) treatment, patients need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness.With 3 month as a time point, they were observed for two points.After the experiment, the experimental data will be arranged and the data of the thickness change of skin lesions will be statistically processed (t test) to determine whether it is meaningful.

Interventions

DRUGTranilast

Subjects will be treated with tranilast

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* (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.

Exclusion criteria

* (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.

Design outcomes

Primary

Measure	Time frame	Description
Measure the volume change of skin lesions by ultrasound	This experiment will last for 6 months	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

Contacts

Primary ContactMaihua Hou, professor

houmaihua@jsph.org.cn+86 13776635881

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026