Study on the Clinical Features, Comorbidities and Pathologies Associated With Pyoderma Gangrenosum

NCT ID: NCT03636737

Last Updated: 2018-08-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pyoderma gangrenosum (PG) is a rare disease. She is often under diagnosed and a source of diagnostic wandering and inadequate care. Moreover, its association in more than one case out of two to a significant underlying pathology, such as inflammatory bowel disease, inflammatory rheumatism, or hematology, makes its diagnosis essential. Its pathophysiological mechanisms remain controversial and many other comorbidities have been reported in the literature, including endocrinological, cardiovascular and metabolic, neoplastic and autoimmune comorbidities.

The objective is to study the field, comorbidities and pathologies associated with PG on a series of patients diagnosed with PG, as well as to characterize the clinical and histological aspects of lesions.

A retrospective observational non-interventional multicenter study is proposed. 10 French centers. The recruitment will be done via the DIM using coding software: codes L984 , L982 and L97 according to 2 major criteria (typical clinical appearance with ulceration well limited and purulent or pustule hutches, exclusion of differential diagnoses) and at least 2 minor criteria (among compatible histological aspect, classically compatible associated pathologies, corticosensitivity of lesions, pathergie phenomenon, painful lesions).

Demographic data, clinical appearance of the lesions, cardiovascular and metabolic comorbidities, other associated pathologies, histological findings of the ulcer biopsy and biological results to describe the population and associated pathologies or comorbidities to PG

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pyoderma gangrenosum (PG) is a rare disease. She is often under diagnosed and a source of diagnostic wandering and inadequate care. Moreover, its association in more than one case out of two to a significant underlying pathology, such as inflammatory bowel disease, inflammatory rheumatism, or hematology, makes its diagnosis essential. Its pathophysiological mechanisms remain controversial and many other comorbidities have been reported in the literature, including endocrinological, cardiovascular and metabolic, neoplastic and autoimmune comorbidities.

The objective is to study the field, comorbidities and pathologies associated with PG on a series of patients diagnosed with PG, as well as to characterize the clinical and histological aspects of lesions.

A retrospective observational non-interventional multicenter study is proposed. 10 French centers. The recruitment will be done via the DIM using coding software: codes L984 (chronic skin ulceration), L982 (febrile neutrophilic dermatosis) and L97 (leg ulcer) according to 2 major criteria (typical clinical appearance with ulceration well limited and purulent or pustule hutches, exclusion of differential diagnoses) and at least 2 minor criteria (among compatible histological aspect, classically compatible associated pathologies, corticosensitivity of lesions, pathergie phenomenon, painful lesions).

Demographic data, clinical appearance of the lesions, cardiovascular and metabolic comorbidities, other associated pathologies, histological findings of the ulcer biopsy and biological results to describe the population and associated pathologies or comorbidities to PG

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pyoderma Gangrenosum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental group

Patients with Pyoderma gangrenosum

pathology associated

Intervention Type OTHER

list of pathology associated to Pyoderma gangrenosum

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pathology associated

list of pathology associated to Pyoderma gangrenosum

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 2 major criteria (typical clinical appearance with well-defined ulceration and purulent or pustule hutches, exclusion of differential diagnoses)
* at least 2 minor criteria (among compatible histological aspect, classically compatible associated pathologies, corticosensitivity of the lesions, pathergie phenomenon, painful lesions).

Exclusion Criteria

* patients with less than 2 major criteria
* patients with less than 2 minor criteria
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

EMILIE GARRIDO PRADALIE

Role: STUDY_DIRECTOR

APHM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

PHILIPPE BERBIS, MD

Role: CONTACT

0491964962

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

PHILIPPE BERBIS, MD

Role: primary

+33 491964962

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RCAPHM17_0083

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Platelet Gel in Systemic Sclerosis
NCT00463125 UNKNOWN PHASE2/PHASE3
Diabetes and Psoriasis
NCT02366273 COMPLETED