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Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers

NCT00709631 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 155

Last updated 2015-02-25

No results posted yet for this study

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.

Conditions

  • Chronic Leg Ulcers

Sponsors & Collaborators

  • Société de Dermatologie Française

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Patricia SENET, MD · AP-HP, Hôpital Charles Foix, 94205 Ivry/Seine, France et Hôpital Tenon, 75020 Paris, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-06-30
Completion
2010-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00709631 on ClinicalTrials.gov