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

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT02889913
Collaborator
(none)
100
1
5.9
16.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention only description

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 Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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 Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France France 75014

Sponsors and Collaborators

  • Groupe Hospitalier Paris Saint Joseph

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT02889913
Other Study ID Numbers:
  • Biopsie cutanĂ©e
First Posted:
Sep 7, 2016
Last Update Posted:
Sep 7, 2016
Last Verified:
Aug 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2016