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

23:36 EDT 1st July 2015 | BioPortfolio

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.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Chronic Leg Ulcers

Location

Patricia SENET, MD
Ivry sur Seine
Ile de France
France
94205

Status

Completed

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Clinical Trials [194 Associated Clinical Trials listed on BioPortfolio]

Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers

The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has a...

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Taliderm Dressing for Venous Ulcers

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PubMed Articles [6920 Associated PubMed Articles listed on BioPortfolio]

Surgical Treatment of Large Vascular Leg Ulcers: A Retrospective Review Evaluating Risk Factors for Healing and Recurrence.

Superficial reflux ablation and revascularization improve the long-term prognosis of venous and arterial leg ulcers but do not solve the problem of protracted healing of large chronic wounds. Skin gra...

Marjolin's ulcer in scarred tissue and non-healing ulcers.

The term "Marjolin's ulcer" describes the formation of a malignant tumour in chronically inflamed skin such as non-healing ulcers or previously traumatized, burned or scarred tissue. Usually the patie...

Contact sensitization to modern dressings: a multicentre study on 354 patients with chronic leg ulcers.

Modern dressings (MDs) may have a low sensitization rate, but there is a lack of prospective studies in patients with chronic leg ulcers (CLUs) to evaluate this.

Limits and possibilities experienced by nurses in the treatment of women with chronic venous ulcers.

Objective To understand the experiences and expectations of nurses in the treatment of women with chronic venous ulcers. Method Phenomenological research was based on Alfred Schütz, whose statements ...

A Retrospective Study of the Effects of Clostridial Collagenase Ointment and Negative Pressure Wound Therapy for the Treatment of Chronic Pressure Ulcers.

Nonhealing, chronic pressure ulcers present a continuous challenge in the global health care venue, with decreased mobility and the effects of aging on skin placing the elderly at particular risk. Deb...

Medical and Biotech [MESH] Definitions

A chronic suppurative and cicatricial disease of the apocrine glands occurring chiefly in the axillae in women and in the groin and anal regions in men. It is characterized by poral occlusion with secondary bacterial infection, evolving into abscesses which eventually rupture. As the disease becomes chronic, ulcers appear, sinus tracts enlarge, fistulas develop, and fibrosis and scarring become evident.

An idiopathic, rapidly evolving, and severely debilitating disease occurring most commonly in association with chronic ulcerative colitis. It is characterized by the presence of boggy, purplish ulcers with undermined borders, appearing mostly on the legs. The majority of cases are in people between 40 and 60 years old. Its etiology is unknown.

A subcategory of CHRONIC OBSTRUCTIVE PULMONARY DISEASE. The disease is characterized by hypersecretion of mucus accompanied by a chronic (more than 3 months in 2 consecutive years) productive cough. Infectious agents are a major cause of chronic bronchitis.

A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.

Chronic inflammation and loss of PERIODONTIUM that is associated with the amount of DENTAL PLAQUE or DENTAL CALCULUS present. Chronic periodontitis occurs mostly in adults and was called adult periodontitis, but this disease can appear in young people.

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