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

This study has been completed.
Sponsor:
Collaborator:
Société de Dermatologie Française
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00709631
First received: July 2, 2008
Last updated: September 15, 2012
Last verified: June 2010

July 2, 2008
September 15, 2012
December 2006
June 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00709631 on ClinicalTrials.gov Archive Site
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Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers
Prospective Evaluation of the Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with one or more leg ulcers, diagnosed as related to venous insufficiency, associated or not with concomitant arterial insufficiency.

Chronic Leg Ulcers
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
May 2010
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • hypertensive ulcer
  • vasculitis
  • treatment by cytotoxic agents or steroids in the previous 3 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00709631
00006477
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Société de Dermatologie Française
Principal Investigator: Patricia SENET, MD AP-HP, Hôpital Charles Foix, 94205 Ivry/Seine, France et Hôpital Tenon, 75020 Paris, France
Assistance Publique - Hôpitaux de Paris
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP