Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma
POPSUD
Pilot Study of descriPtion of cicatriSation Rates of Digital Ulcers in Systemic scleroDerma
1 other identifier
observational
78
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
Longer than P75 for all trials
3 active sites
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
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedStudy Start
First participant enrolled
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMay 6, 2023
May 1, 2023
5 years
March 20, 2020
May 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of digital ulcers
Number of digital ulcers healed at the end of the study
1 year
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Patient with systemic scleroderma
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Bordeaux Hospital
Bordeaux, 33000, France
Limoges Hospital
Limoges, 87042, France
Toulouse Hospital
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2020
First Posted
March 24, 2020
Study Start
December 17, 2020
Primary Completion
December 1, 2025
Study Completion
May 1, 2026
Last Updated
May 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share