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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Pyoderma Gangrenosum

Treatments

Other: pathology associated

Study type

Observational

Funder types

Other

Identifiers

NCT03636737
RCAPHM17_0083

Details and patient eligibility

About

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

Full description

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

Enrollment

140 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

140 participants in 1 patient group

experimental group
Description:
Patients with Pyoderma gangrenosum
Treatment:
Other: pathology associated

Trial contacts and locations

1

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Central trial contact

PHILIPPE BERBIS, MD

Data sourced from clinicaltrials.gov

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