Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers
ULCERE
Prospective Evaluation of the Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers
1 other identifier
observational
155
1 country
1
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 months of adequate treatmentSecondary aims of the study : to evaluate the interest of immunostainings for desmogleins 1-2 and p16 on biopsies to differentiate between pseudo epitheliomatous hyperplasia and squamous cell carcinoma ; and the prognosis of diagnosed carcinomas at 12 monthsStudy hypothesis : systematic biopsies of hard-to-heal leg ulcer may help to detect ulcerated carcinomas misdiagnosed as vascular ulcer or malignant degeneration of leg ulcer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 2, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFebruary 25, 2015
June 1, 2010
2.5 years
July 2, 2008
February 24, 2015
Conditions
Keywords
Eligibility Criteria
Patients with one or more leg ulcers, diagnosed as related to venous insufficiency, associated or not with concomitant arterial insufficiency.
You may qualify if:
- 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
You may not qualify if:
- hypertensive ulcer
- vasculitis
- treatment by cytotoxic agents or steroids in the previous 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Patricia SENET, MD
Ivry-sur-Seine, Île-de-France Region, 94205, France
Related Publications (1)
Senet P, Combemale P, Debure C, Baudot N, Machet L, Aout M, Vicaut E, Lok C; Angio-Dermatology Group Of The French Society Of Dermatology. Malignancy and chronic leg ulcers: the value of systematic wound biopsies: a prospective, multicenter, cross-sectional study. Arch Dermatol. 2012 Jun;148(6):704-8. doi: 10.1001/archdermatol.2011.3362.
PMID: 22772403DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia SENET, MD
AP-HP, Hôpital Charles Foix, 94205 Ivry/Seine, France et Hôpital Tenon, 75020 Paris, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2008
First Posted
July 3, 2008
Study Start
December 1, 2006
Primary Completion
June 1, 2009
Study Completion
May 1, 2010
Last Updated
February 25, 2015
Record last verified: 2010-06