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Status unknownNCT03636737PYODERMAUpdated Aug 20, 2018

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

An observational study in Pyoderma Gangrenosum, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2018-08-20.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
140
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Pyoderma Gangrenosum

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03

In context

Pyoderma Gangrenosum

36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.

Browse Pyoderma Gangrenosum studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with pyoderma gangrenosum

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • patients with less than 2 major criteria
  • patients with less than 2 minor criteria
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • experimental group

    Patients with Pyoderma gangrenosum

    Other: pathology associated

Interventions

  • Otherpathology associated

    list of pathology associated to Pyoderma gangrenosum

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What researchers measure

Primary outcomes

  1. Number of patients

    Number of patients with Pyoderma gangrenosum and associated pathology

    Time frame: 1 months

07

Study locations

1 site
  • Assistance Publique Des Hopitaux de Marseille
    Marseille, Paca 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03636737
Responsible party
Sponsor
First posted
Aug 17, 2018
Start date
Dec 2018 (estimated)
Primary completion
Jun 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Aug 20, 2018

Study contacts

PHILIPPE BERBIS, MD
Contact
Philippe.BERBIS@ap-hm.fr
0491964962
EMILIE GARRIDO PRADALIE
study director · APHM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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