Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Not Applicable

Completed

• Conditions: Leg Ulcer
• Interventions: Other: Psychological tests

• Registration Number: NCT01673412
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Study First Submitted: 2012-07-31
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-23
• Last Update Submitted: 2012-08-23
• Study First Posted: 2012-08-28
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interventional arm	Psychological tests	Psychological tests

Primary Outcome Measures

Name	Time	Method
Healing or non-healing of venous leg ulcers at week 24	week 24	Healing or non-healing of venous leg ulcers at week 24

Secondary Outcome Measures

Name	Time	Method
affected-leg characteristics	week 24	comparison between healed and non healed venous leg ulcers at week 24 for patient affected-leg inclusion characteristics (venous insufficiency classified using CEAP classification, ultrasonography assessment of leg with measurement of the Ankle Brachial Index (ABI) and examination of the leg venous system, number of ulcers on target leg, presence/absence of venous abnormalities (varicose veins, ochre dermatitis, white atrophy, acute hypodermitis), of cutaneous signs of lymphatic insufficiency, of oedema and of ankle articulation ankylosis)
clinical characteristics	week 24	comparison between healed and non healed venous leg ulcers at week 24 for patient clinical characteristics (age, weight, body mass index, concomitant diseases, medical and surgical history, autonomy, mobility)
psychologic assessments	week 24	comparison between healed and non healed venous leg ulcers at week 24 for patient psychologic assessments (self-esteem assessed by Coopersmith self-esteem inventory, symptoms of depression researched with Beck Depression Inventory)
cognitive assessments	week 24	comparison between healed and non healed venous leg ulcers at week 24 for patient cognitive assessments (intellectual quotient evaluated by Raven's progressives matrices test, signs of intellectual deterioration assessed by Minimal Mental Status test)
social assessment	week 24	comparison between healed and non healed venous leg ulcers at week 24 for patient social assessments (assessment of social and occupational group, of education level, of income level and of marital status)
venous leg ulcers inclusion characteristics	week 24	comparison between healed and non healed venous leg ulcers at week 24 for patient venous leg ulcers inclusion characteristics (size, localization, duration, percentage of granulation/fibrinous tissue, aspect of ulcer's margins, pain)
venous insufficiency treatment	week 24	comparison between healed and non healed venous leg ulcers at week 24 for patient venous insufficiency treatment (compliance to venous contention assessed by an evaluating questionnaire)
biologic characteristics	week 24	comparison between healed and non healed venous leg ulcers at week 24 for patient biologic characteristics (complete blood count, hemoglobinemia, albuminemia, and only for patients with diabetes mellitus : glycemia and glycated haemoglobin)

Trial Locations

Locations (35)

CHU Trousseau - Dermatologie; 🇫🇷 Tours, France

Hôpital Beauregard; 🇫🇷 Thionville, France

Cabinet de Dermatologie 1,rue dembarrère; 🇫🇷 Tarbes, France

CHRU Dupuytren - Dermatologie; 🇫🇷 Limoges, France

Centre Hospitalier de Valence - Dermatologie; 🇫🇷 Valence, France

Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I; 🇫🇷 Amiens, France

Centre Hospitalo-Universitaire d'Amiens - Dermatologie; 🇫🇷 Amiens, France

Hôpital Victor Dupouy - Dermatologie; 🇫🇷 Argenteuil, France

Hôpital Saint Jacques - Dermatologie 1; 🇫🇷 Besançon, France

CHU de Brest - Dermatologie; 🇫🇷 Brest, France

CHU Clémenceau - Dermatologie; 🇫🇷 Caen, France

CHU Michallon - Dermatologie; 🇫🇷 Grenoble, France

Hôpitaux Civils de Colmar - Service de Dermatologie; 🇫🇷 Colmar, France

CHU Bocage - Dermatologie; 🇫🇷 Dijon, France

Hôpital C. Foix - Service de Gérontologie; 🇫🇷 Ivry, France

Centre Hospitalier - Service de Médecine Interne; 🇫🇷 Lens, France

Hôpital Robert Boulin - Dermatologie; 🇫🇷 Libourne, France

Hôpital Saint Philibert - Dermatologie; 🇫🇷 Lomme, France

Hôpital Claude Huriez - Clinique Dermatologique; 🇫🇷 Lille, France

CHU Pontchaillou; 🇫🇷 Rennes, France

Cabinet de Dermatologie 43, rue Jean Lecanuet; 🇫🇷 Rouen, France

Hôpital d'Instruction des Armées Desgenettes; 🇫🇷 Lyon, France

Hôpital Sainte Marguerite - Dermatologie; 🇫🇷 Marseille, France

Hôpital SAint Charles - Dermatologie; 🇫🇷 Montpellier, France

Hôpital Fournier; 🇫🇷 Nancy, France

Hôpital Rothschild - Consultation de Dermatologie; 🇫🇷 Paris, France

CHU Bichat - Service de Dermatologie; 🇫🇷 Paris, France

Hôpital Saint Louis - Service de Dermatologie; 🇫🇷 Paris, France

Hôpital Broussais - Rééducation Vasculaire; 🇫🇷 Paris, France

Hôpital du Haut Levêque - Dermatologie; 🇫🇷 Pessac, France

Hôpital Charles NICOLLE - Service de Dermatologie; 🇫🇷 Rouen, France

Centre Hospitalier Laennec - Dermatologie; 🇫🇷 Quimper, France

CHU Robert Debré; 🇫🇷 Reims, France

Le Royal Parc - Dermatologie; 🇫🇷 Saint Brieuc, France

Centre Hospitalier Intercommunal Poissy Saint Germain; 🇫🇷 Saint Germain en Laye, France