Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers
2 other identifiers
interventional
104
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2003
Longer than P75 for not_applicable
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 31, 2012
CompletedFirst Posted
Study publicly available on registry
August 28, 2012
CompletedSeptember 22, 2025
September 1, 2025
5.4 years
July 31, 2012
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
clinical characteristics
week 24
biologic characteristics
week 24
psychologic assessments
week 24
cognitive assessments
week 24
social assessment
week 24
- +3 more secondary outcomes
Study Arms (1)
interventional arm
EXPERIMENTALPsychological tests
Interventions
social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Centre Hospitalo-Universitaire d'Amiens - Dermatologie
Amiens, 80000, France
Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I
Amiens, 80000, France
Hôpital Victor Dupouy - Dermatologie
Argenteuil, 95100, France
Hôpital Saint Jacques - Dermatologie 1
Besançon, 25030, France
CHU de Brest - Dermatologie
Brest, 29609, France
CHU Clémenceau - Dermatologie
Caen, 14033, France
Hôpitaux Civils de Colmar - Service de Dermatologie
Colmar, 68024, France
CHU Bocage - Dermatologie
Dijon, 21034, France
CHU Michallon - Dermatologie
Grenoble, 38043, France
Hôpital C. Foix - Service de Gérontologie
Ivry, 94205, France
Centre Hospitalier - Service de Médecine Interne
Lens, 62307, France
Hôpital Robert Boulin - Dermatologie
Libourne, 33500, France
Hôpital Claude Huriez - Clinique Dermatologique
Lille, 59037, France
CHRU Dupuytren - Dermatologie
Limoges, 87042, France
Hôpital Saint Philibert - Dermatologie
Lomme, 59462, France
Hôpital d'Instruction des Armées Desgenettes
Lyon, 69998, France
Hôpital Sainte Marguerite - Dermatologie
Marseille, 13009, France
Hôpital SAint Charles - Dermatologie
Montpellier, 34295, France
Hôpital Fournier
Nancy, 54000, France
Hôpital Rothschild - Consultation de Dermatologie
Paris, 75012, France
CHU Bichat - Service de Dermatologie
Paris, 75018, France
Hôpital Saint Louis - Service de Dermatologie
Paris, 75475, France
Hôpital Broussais - Rééducation Vasculaire
Paris, 75674, France
Hôpital du Haut Levêque - Dermatologie
Pessac, 33604, France
Centre Hospitalier Laennec - Dermatologie
Quimper, 29107, France
CHU Robert Debré
Reims, 51092, France
CHU Pontchaillou
Rennes, 35033, France
Cabinet de Dermatologie 43, rue Jean Lecanuet
Rouen, 76000, France
Hôpital Charles NICOLLE - Service de Dermatologie
Rouen, 76031, France
Le Royal Parc - Dermatologie
Saint-Brieuc, 22000, France
Centre Hospitalier Intercommunal Poissy Saint Germain
Saint-Germain-en-Laye, 78100, France
Cabinet de Dermatologie 1,rue dembarrère
Tarbes, 65000, France
Hôpital Beauregard
Thionville, 57100, France
CHU Trousseau - Dermatologie
Tours, 37044, France
Centre Hospitalier de Valence - Dermatologie
Valence, 26000, France
Related Publications (1)
Chaby G, Senet P, Ganry O, Caudron A, Thuillier D, Debure C, Meaume S, Truchetet F, Combemale P, Skowron F, Joly P, Lok C; Angio-Dermatology Group of the French Society of Dermatology. Prognostic factors associated with healing of venous leg ulcers: a multicentre, prospective, cohort study. Br J Dermatol. 2013 Nov;169(5):1106-13. doi: 10.1111/bjd.12570.
PMID: 23909381RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine LOK, PhD
Centre Hospitalo-Universitaire d'Amiens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2012
First Posted
August 28, 2012
Study Start
January 1, 2003
Primary Completion
June 1, 2008
Study Completion
December 1, 2008
Last Updated
September 22, 2025
Record last verified: 2025-09