Clinical trial NCT02889913: When Asking the Indication of a Skin Biopsy From a Patient With a Leg Ulcer in Primary Care?
Official title: When Asking the Indication of a Skin Biopsy From a Patient With a Leg Ulcer in Primary Care? Retrospective Study of 100 Consecutive Biopsies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Ulcer
Leg Ulcer
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The last 100 consecutive skin biopsies performed in patients carriers of chronic leg ulcers, hospitalized in the vascular medicine department of the Hospital Saint Joseph Paris

Brief summary: Leg ulcers are frequent. There are no epidemiological studies available in France, but international studies estimate the prevalence between 0.045 and 0.63% of the total population, prevalence increases with age, reaching 5% of patients over 80 years. Extrapolating these prevalences in the French population between 28 000 and 395 000 people are affected in France a leg ulcer.

It is a costly disease. In 2001, a French study conducted among 800 physicians, including 85.7% of general practitioners, involving more than 1000 patients with venous ulcers, it was estimated that the total cost of treatment per patient average was 888 32 euros. This is truly a public health problem.

Leg ulcers are in 80% of cases of vascular causes (venous, arterial or arteriovenous mixed). However, there are rare causes of ulcers: skin carcinoma, infectious ulcers and vasculitis. These ulcers rare causes require specific treatments that can often heal. To diagnose, to perform a skin biopsy. Thus, the general practitioner must know when to put the indication for biopsy of a leg ulcer.

Detailed description: Goal :

Analyzing the last 100 consecutive skin biopsies performed in patients carriers of chronic leg ulcers, followed in the vascular medicine department of the Hospital Saint Joseph Paris, to determine:

* The reasons which motivated the doctor make the indication of biopsy:
* Disease duration of ulcer
* Unusual clinical features
* Other signs associated with ulcer
* Absence of a satisfactory explanation vascular
* The pathological results Purpose: To clear a typical profile ulcers biopsy

Methodology :

* Retrospective, single-center,
* Acquisition of data: via the pathology laboratory of the hospital will be collected the last 100 consecutive biopsies performed with leg ulcers in vascular medicine department of the hospital Saint Joseph Paris, between 1 January 2013 and the October 1, 2013. Then be analyzed all paper and electronic records of these patients.
* Grid and Analysis:

  * Patient histories,
  * vascular profile of patients,
  * clinical and chronological criteria of the ulcer,
  * Other signs associated with ulcer
  * Results of histological biopsies.
* The data will be made anonymous on the grid for collection by a numbering system 1 100.

Eligibility criteria: Inclusion Criteria:

* The last 100 consecutive skin biopsies performed in patients carriers of chronic leg ulcers, hospitalized in the vascular medicine department of the Hospital Saint Joseph Paris

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Assessment of disease duration of ulcer
timeFrame: Day 1 of ulceration to the day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References: