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

NCT ID: NCT04319120

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-17

Study Completion Date

2026-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Scleroderma, Systemic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

questionnaires online

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bordeaux Hospital

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Limoges Hospital

Limoges, , France

Site Status RECRUITING

Toulouse Hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nolga BOUSSELY

Role: CONTACT

0555056959

Facility Contacts

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Stéphanie COMOZ

Role: primary

Nolga BOUSSELY

Role: primary

François-Xavier LAPEBIE

Role: primary

Other Identifiers

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87RI18_0017

Identifier Type: -

Identifier Source: org_study_id

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