When Asking the Indication of a Skin Biopsy From a Patient With a Leg Ulcer in Primary Care?

Completed

• Conditions: Leg Ulcer; Varicose Ulcer

• Registration Number: NCT02889913
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Study First Posted: 2016-09-07
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of disease duration of ulcer	Day 1 of ulceration to the day 30	by calculating the number of days from ulceration to the healing

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint Joseph; 🇫🇷 Paris, Ile-de-France, France