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NCT04319120 Clinical Trial

Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma

Scleroderma, Systemic Clinical Trial

— POPSUD  

Official title:
Pilot Study of descriPtion of cicatriSation Rates of Digital Ulcers in Systemic scleroDerma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04319120
Other study ID # 87RI18_0017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 17, 2020
Est. completion date May 2026

Study information
Verified date May 2023
Source University Hospital, Limoges
Contact Nolga BOUSSELY
Phone 0555056959
Email Nolga.boussely@chu-limoges.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To make an updated inventory of digital ulcer care protocols in scleroderma patients and to specify the French data on monthly healing rates and local care with patients in care centers experience, and thus to know the impact of ulcers in different dimensions To evaluate the rate of healed digital ulcers at the end of the study

Recruitment information / eligibility
Status Recruiting
Enrollment 78
Est. completion date May 2026
Est. primary completion date December 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with systemic scleroderma according to the ACR / EULAR 2012 criteria - Patient with one or more active digital ulcers - Patient with internet access and camera or smartphone Exclusion Criteria: - Minor patients - Patient deprived of liberty or subject to a court order - Patient subject to a legal protection measure - Pregnant or lactating woman - Patient unable to complete the questionnaires

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• questionnaires online
Each month, the nurse will contact the patients included, by mail or telephone, to fill out their questionnaires online or by mail, and to make a photo of the ulcer if it is healed. A dedicated telephone line and e-mail address will be used as a support if necessary (for questionnaires, emails or sending photos). The referring nurse and the clinical research assistant of the service will be in charge of centralizing the data collected.

Locations
Country Name City State
France Bordeaux Hospital Bordeaux
France Limoges Hospital Limoges
France Toulouse Hospital Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of digital ulcers Number of digital ulcers healed at the end of the study 1 year
See also
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