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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319120
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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

Condition or disease Intervention/treatment
Scleroderma, Systemic Other: questionnaires online

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Study Type : Observational
Estimated Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of descriPtion of cicatriSation Rates of Digital Ulcers in Systemic scleroDerma
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

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.




Primary Outcome Measures :
  1. Number of digital ulcers [ Time Frame: 1 year ]
    Number of digital ulcers healed at the end of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patient with systemic scleroderma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319120


Contacts
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Contact: Noemie MARCHAT +33 5 55 05 69 90 Noemie.marchat@chu-limoges.fr

Locations
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France
Bordeaux Hospital Not yet recruiting
Bordeaux, France, 33000
Contact: Stéphanie COMOZ         
Principal Investigator: Stéphanie COMOZ         
Limoges Hospital Recruiting
Limoges, France, 87042
Contact: Noemie MARCHAT         
Principal Investigator: Noemie MARCHAT         
Sponsors and Collaborators
University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT04319120    
Other Study ID Numbers: 87RI18_0017
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
Scleroderma - Digital Ulcers
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Cicatrix
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Fibrosis