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

NCT ID: NCT02889913

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-07-31

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.

Conditions

Varicose Ulcer; Leg Ulcer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

No intervention only description

No intervention only description

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

Biopsie cutanée

Identifier Type: -

Identifier Source: org_study_id