Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcer
• Intervention / Treatment: Other: Psychological tests

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Centre Hospitalo-Universitaire d'Amiens - Dermatologie
  • Amiens, France, 80000
    • Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I
  • Argenteuil, France, 95100
    • Hôpital Victor Dupouy - Dermatologie
  • Besançon, France, 25030
    • Hôpital Saint Jacques - Dermatologie 1
  • Brest, France, 29609
    • CHU de Brest - Dermatologie
  • Caen, France, 14033
    • CHU Clémenceau - Dermatologie
  • Colmar, France, 68024
    • Hôpitaux Civils de Colmar - Service de Dermatologie
  • Dijon, France, 21034
    • CHU Bocage - Dermatologie
  • Grenoble, France, 38043
    • CHU Michallon - Dermatologie
  • Ivry, France, 94205
    • Hôpital C. Foix - Service de Gérontologie
  • Lens, France, 62307
    • Centre Hospitalier - Service de Médecine Interne
  • Libourne, France, 33500
    • Hôpital Robert Boulin - Dermatologie
  • Lille, France, 59037
    • Hôpital Claude Huriez - Clinique Dermatologique
  • Limoges, France, 87042
    • CHRU Dupuytren - Dermatologie
  • Lomme, France, 59462
    • Hôpital Saint Philibert - Dermatologie
  • Lyon, France, 69998
    • Hopital d'Instruction des Armées Desgenettes
  • Marseille, France, 13009
    • Hôpital Sainte Marguerite - Dermatologie
  • Montpellier, France, 34295
    • Hôpital SAint Charles - Dermatologie
  • Nancy, France, 54000
    • Hôpital Fournier
  • Paris, France, 75012
    • Hôpital Rothschild - Consultation de Dermatologie
  • Paris, France, 75018
    • CHU Bichat - Service de Dermatologie
  • Paris, France, 75475
    • Hôpital Saint Louis - Service de Dermatologie
  • Paris, France, 75674
    • Hôpital Broussais - Rééducation Vasculaire
  • Pessac, France, 33604
    • Hôpital du Haut Levêque - Dermatologie
  • Quimper, France, 29107
    • Centre Hospitalier Laennec - Dermatologie
  • Reims, France, 51092
    • CHU Robert Debré
  • Rennes, France, 35033
    • CHU Pontchaillou
  • Rouen, France, 76000
    • Cabinet de Dermatologie 43, rue Jean Lecanuet
  • Rouen, France, 76031
    • Hôpital Charles NICOLLE - Service de Dermatologie
  • Saint Brieuc, France, 22000
    • Le Royal Parc - Dermatologie
  • Saint Germain en Laye, France, 78100
    • Centre Hospitalier Intercommunal Poissy Saint Germain
  • Tarbes, France, 65000
    • Cabinet de Dermatologie 1,rue dembarrère
  • Thionville, France, 57100
    • Hôpital Beauregard
  • Tours, France, 37044
    • CHU Trousseau - Dermatologie
  • Valence, France, 26000
    • Centre Hospitalier de Valence - Dermatologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: interventional arm; Psychological tests	Other: Psychological tests; social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing or non-healing of venous leg ulcers at week 24	Healing or non-healing of venous leg ulcers at week 24	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical characteristics	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)	week 24
biologic characteristics	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)	week 24
psychologic assessments	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)	week 24
cognitive assessments	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)	week 24
social assessment	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)	week 24
affected-leg characteristics	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)	week 24
venous leg ulcers inclusion characteristics	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)	week 24
venous insufficiency treatment	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)	week 24

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Société de Dermatologie Française; Institut de Recherches Internationales Servier
• Investigators: Principal Investigator: Catherine LOK, PhD, Centre Hospitalo-Universitaire d'Amiens

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: July 31, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (ESTIMATE): August 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 28, 2012
• Last Update Submitted That Met QC Criteria: August 23, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: venous leg ulcer healing prognostic factors
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: AOL02-DR-LOK; 02H37 (OTHER: CPP Nord-Ouest II)