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

NCT03636737 | Unknown

• 1 other identifier: RCAPHM17_0083
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pyoderma Gangrenosum

Outcome Measures

Primary Outcomes (1)

• Number of patients

  Number of patients with Pyoderma gangrenosum and associated pathology

  1 months

Study Arms (1)

experimental group

Patients with Pyoderma gangrenosum

Other: pathology associated

Interventions

pathology associated OTHER

list of pathology associated to Pyoderma gangrenosum

experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with pyoderma gangrenosum

You may qualify if:

• at least 2 minor criteria (among compatible histological aspect, classically compatible associated pathologies, corticosensitivity of the lesions, pathergie phenomenon, painful lesions).

You may not qualify if:

• patients with less than 2 major criteria
• patients with less than 2 minor criteria

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

PHILIPPE BERBIS, MD

CONTACT

0491964962; Philippe.BERBIS@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 17, 2018
• Study Start: December 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

FR (1)