Text Size

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
History of Changes
  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
Chronic Leg Ulcers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Enrollment: 155
Study Start Date: December 2006
Study Completion Date: May 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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 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
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709631

Locations
France
Patricia SENET, MD
Ivry sur Seine, Ile de France, France, 94205
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Société de Dermatologie Française
Investigators
Principal Investigator: Patricia SENET, MD AP-HP, Hôpital Charles Foix, 94205 Ivry/Seine, France et Hôpital Tenon, 75020 Paris, France
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00709631     History of Changes
Other Study ID Numbers: 00006477
Study First Received: July 2, 2008
Last Updated: September 15, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Malignant transformation of leg ulcer
MARJOLIN's ulcer
Biopsy
Leg ulcer
 Chronic wound
Squamous cell carcinoma
Basal cell carcinoma

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013