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| Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Société Française de Dermatologie (Bourse URGO) |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00709631 |
Purpose
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.
| Condition |
|---|
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Chronic Leg Ulcers |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Prospective Evaluation of the Interest of a Systematic Biopsy for Hard-to-Heal Leg Ulcers |
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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 consisted of consecutive patients with one or more leg ulcers, diagnosed as related to venous insufficiency, associated or not with concomitant arterial insufficiency. All patients undergo a standard treatment including compression therapy adapted to the ankle brachial index and a local treatment depending on the wound stage.At inclusion, systematic punch biopsies (5-6 mm) are taken as part of routine clinical care under local anaesthetic by an experienced clinician: 1 to 2 biopsies in the edges and 1 to 2 biopsies in the wound bedSpecimens are transported in formalin solution to the usual pathology laboratory of the investigator. At the end of the study, specimens will be sent for immunostainings in a single pathology laboratory (Rouen, France)Treatments and/or other investigations are decided by the investigatorAt 12 months of usual follow-up, final diagnosis and prognosis are noted in the study file by the investigator.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with one or more leg ulcers, diagnosed as related to venous insufficiency, associated or not with concomitant arterial insufficiency.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France, Ile de France | |
| Patricia SENET, MD | Recruiting |
| Ivry sur Seine, Ile de France, France, 94205 | |
| Contact: Patricia SENET, MD +33 1 49 59 45 05 patricia.senet@cfx.aphp.fr | |
| Principal Investigator: Patricia SENET, MD | |
| Principal Investigator: | Patricia SENET, MD | AP-HP, Hôpital Charles Foix, 94205 Ivry/Seine, France et Hôpital Tenon, 75020 Paris, France |
More Information
| Responsible Party: | Hôpital Charles Foix, 94205 Ivry/Seine et Hôpital Tenon, 75020 Paris ( Senet Patricia, MD ) |
| Study ID Numbers: | 00006477 |
| Study First Received: | July 2, 2008 |
| Last Updated: | July 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00709631 |
| Health Authority: | France: Ministry of Health |
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Malignant transformation of leg ulcer MARJOLIN's ulcer Biopsy Leg ulcer |
Chronic wound Squamous cell carcinoma Basal cell carcinoma |
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Epidermoid carcinoma Skin Diseases Squamous cell carcinoma Ulcer Carcinoma, squamous cell |
Carcinoma, Basal Cell Skin Ulcer Carcinoma, Squamous Cell Leg Ulcer Carcinoma |
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Pathologic Processes |
