Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma (POPSUD)

May 4, 2023 updated by: University Hospital, Limoges

Pilot Study of descriPtion of cicatriSation Rates of Digital Ulcers in Systemic scleroDerma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
        • Not yet recruiting
        • Bordeaux Hospital
        • Contact:
          • Stéphanie COMOZ
        • Principal Investigator:
          • Stéphanie COMOZ
      • Limoges, France, 87042
        • Recruiting
        • Limoges hospital
        • Contact:
          • Nolga BOUSSELY
        • Principal Investigator:
          • Nolga BOUSSELY
      • Toulouse, France, 31000
        • Recruiting
        • Toulouse Hospital
        • Contact:
          • François-Xavier LAPEBIE
        • Principal Investigator:
          • François-Xavier LAPEBIE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patient with systemic scleroderma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of digital ulcers
Time Frame: 1 year
Number of digital ulcers healed at the end of the study
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI18_0017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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