Clinical trial NCT01673412: Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers
Official title: Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcer
Keywords: venous leg ulcer healing prognostic factors
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Institut de Recherches Internationales Servier
name: Société de Dermatologie Française
First posted: 2012-08-28
Enrollment: 104
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU) characteristics known as possible prognostic markers, and which sociodemographic and psychologic factors associated with VLU are associated with complete healing at 24 weeks.


Eligibility criteria: Inclusion Criteria:

* ambulatory or hospitalized patients
* patients over 50 years old
* one or more venous leg ulcer, lasting for 1 month or more
* wound area more than 1 cm2
* clinical findings consistent with established venous disease (skin hyperpigmentation, varicose veins, lipodermatosclerosis), confirmed by venous Doppler duplex ultrasonography performed during the preceding 6 months
* absence of significant arterial insufficiency assessed by clinical findings (intermittent claudication or resting pain, necrotic or distal foot wound) and by an ankle brachial index (ABI) ≥0.8
* ability to give informed consent
* ability to be followed for 24 weeks

Exclusion Criteria:

* ongoing systemic diseases known to be associated with pyoderma gangrenosum or necrotizing vasculitis
* corticosteroid, cytotoxic or immunosuppressant drug use during the preceding 3 months
* hypertensive leg ulcer
* foot ulcer
* ABI \< 0.8

Primary outcomes:
measure: Healing or non-healing of venous leg ulcers at week 24
timeFrame: week 24
Secondary outcomes:
measure: clinical characteristics
timeFrame: week 24
measure: biologic characteristics
timeFrame: week 24
measure: psychologic assessments
timeFrame: week 24
measure: cognitive assessments
timeFrame: week 24
measure: social assessment
timeFrame: week 24
measure: affected-leg characteristics
timeFrame: week 24
measure: venous leg ulcers inclusion characteristics
timeFrame: week 24
measure: venous insufficiency treatment
timeFrame: week 24
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalo-Universitaire d'Amiens - Dermatologie
city: Amiens
country: France
facility: Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I
city: Argenteuil
country: France
facility: Hôpital Victor Dupouy - Dermatologie
city: Besançon
country: France
facility: Hôpital Saint Jacques - Dermatologie 1
city: Brest
country: France
facility: CHU de Brest - Dermatologie
city: Caen
country: France
facility: CHU Clémenceau - Dermatologie
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar - Service de Dermatologie
city: Dijon
country: France
facility: CHU Bocage - Dermatologie
city: Grenoble
country: France
facility: CHU Michallon - Dermatologie
city: Ivry
country: France
facility: Hôpital C. Foix - Service de Gérontologie
city: Lens
country: France
facility: Centre Hospitalier - Service de Médecine Interne
city: Libourne
country: France
facility: Hôpital Robert Boulin - Dermatologie
city: Lille
country: France
facility: Hôpital Claude Huriez - Clinique Dermatologique
city: Limoges
country: France
facility: CHRU Dupuytren - Dermatologie
city: Lomme
country: France
facility: Hôpital Saint Philibert - Dermatologie
city: Lyon
country: France
facility: Hôpital d'Instruction des Armées Desgenettes
city: Marseille
country: France
facility: Hôpital Sainte Marguerite - Dermatologie
city: Montpellier
country: France
facility: Hôpital SAint Charles - Dermatologie
city: Nancy
country: France
facility: Hôpital Fournier
city: Paris
country: France
facility: Hôpital Rothschild - Consultation de Dermatologie
city: Paris
country: France
facility: CHU Bichat - Service de Dermatologie
city: Paris
country: France
facility: Hôpital Saint Louis - Service de Dermatologie
city: Paris
country: France
facility: Hôpital Broussais - Rééducation Vasculaire
city: Pessac
country: France
facility: Hôpital du Haut Levêque - Dermatologie
city: Quimper
country: France
facility: Centre Hospitalier Laennec - Dermatologie
city: Reims
country: France
facility: CHU Robert Debré
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: Cabinet de Dermatologie 43, rue Jean Lecanuet
city: Rouen
country: France
facility: Hôpital Charles NICOLLE - Service de Dermatologie
city: Saint Brieuc
country: France
facility: Le Royal Parc - Dermatologie
city: Saint Germain en Laye
country: France
facility: Centre Hospitalier Intercommunal Poissy Saint Germain
city: Tarbes
country: France
facility: Cabinet de Dermatologie 1,rue dembarrère
city: Thionville
country: France
facility: Hôpital Beauregard
city: Tours
country: France
facility: CHU Trousseau - Dermatologie
city: Valence
country: France
facility: Centre Hospitalier de Valence - Dermatologie
Study officials:
affiliation: Centre Hospitalo-Universitaire d'Amiens
name: Catherine LOK, PhD
role: PRINCIPAL_INVESTIGATOR
References: