Status:
COMPLETED
Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Société de Dermatologie Française
Conditions:
Chronic Leg Ulcers
Eligibility:
All Genders
18+ years
Brief Summary
Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of healing despite 3 m...
Detailed Description
Prospective multicentric inclusion of 150 patients with leg ulcers without any evidence of healing (no change or increase of ulcer area) despite 3 months of adequate treatment The study population con...
Eligibility Criteria
Inclusion
- leg ulcer of more than 3 months of duration
- leg ulcer presumed of vascular origin
- adequate etiologic treatment since 3 months
- absence of evidence of healing : absence of reduction of wound area or increase in wound area and/or in depth
Exclusion
- hypertensive ulcer
- vasculitis
- treatment by cytotoxic agents or steroids in the previous 3 months
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00709631
Start Date
December 1 2006
End Date
May 1 2010
Last Update
February 25 2015
Active Locations (1)
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1
Patricia SENET, MD
Ivry-sur-Seine, Île-de-France Region, France, 94205