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

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ClinicalTrials.gov Identifier: NCT03636737
Recruitment Status : Unknown
Verified August 2018 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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


Condition or disease Intervention/treatment
Pyoderma Gangrenosum Other: pathology associated

Detailed 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

Study Design
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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Multicenter Observational Study on the Clinical Features, Comorbidities and Pathologies Associated With Pyoderma Gangrenosum in Patients Diagnosed With This Pathology Between 2000 and 2015
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
experimental group
Patients with Pyoderma gangrenosum
 Other: pathology associated
list of pathology associated to Pyoderma gangrenosum


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients [ Time Frame: 1 months ]
    Number of patients with Pyoderma gangrenosum and associated pathology


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with pyoderma gangrenosum
Criteria

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
Contacts and Locations
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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): NCT03636737


Contacts
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Contact: PHILIPPE BERBIS, MD 0491964962 Philippe.BERBIS@ap-hm.fr

Locations
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France
Assistance Publique Des Hopitaux de Marseille
Marseille, Paca, France, 13354
Contact: PHILIPPE BERBIS, MD    +33 491964962    Philippe.BERBIS@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: EMILIE GARRIDO PRADALIE APHM
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03636737    
Other Study ID Numbers: RCAPHM17_0083
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pyoderma
Pyoderma Gangrenosum
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer