Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

NCT ID: NCT01673412

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leg Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

interventional arm

Psychological tests

Group Type EXPERIMENTAL

Psychological tests

Intervention Type OTHER

social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychological tests

social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut de Recherches Internationales Servier

OTHER

Sponsor Role collaborator

Société de Dermatologie Française

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Catherine LOK, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalo-Universitaire d'Amiens

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalo-Universitaire d'Amiens - Dermatologie

Amiens, , France

Site Status

Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I

Amiens, , France

Site Status

Hôpital Victor Dupouy - Dermatologie

Argenteuil, , France

Site Status

Hôpital Saint Jacques - Dermatologie 1

Besançon, , France

Site Status

CHU de Brest - Dermatologie

Brest, , France

Site Status

CHU Clémenceau - Dermatologie

Caen, , France

Site Status

Hôpitaux Civils de Colmar - Service de Dermatologie

Colmar, , France

Site Status

CHU Bocage - Dermatologie

Dijon, , France

Site Status

CHU Michallon - Dermatologie

Grenoble, , France

Site Status

Hôpital C. Foix - Service de Gérontologie

Ivry, , France

Site Status

Centre Hospitalier - Service de Médecine Interne

Lens, , France

Site Status

Hôpital Robert Boulin - Dermatologie

Libourne, , France

Site Status

Hôpital Claude Huriez - Clinique Dermatologique

Lille, , France

Site Status

CHRU Dupuytren - Dermatologie

Limoges, , France

Site Status

Hôpital Saint Philibert - Dermatologie

Lomme, , France

Site Status

Hôpital d'Instruction des Armées Desgenettes

Lyon, , France

Site Status

Hôpital Sainte Marguerite - Dermatologie

Marseille, , France

Site Status

Hôpital SAint Charles - Dermatologie

Montpellier, , France

Site Status

Hôpital Fournier

Nancy, , France

Site Status

Hôpital Rothschild - Consultation de Dermatologie

Paris, , France

Site Status

CHU Bichat - Service de Dermatologie

Paris, , France

Site Status

Hôpital Saint Louis - Service de Dermatologie

Paris, , France

Site Status

Hôpital Broussais - Rééducation Vasculaire

Paris, , France

Site Status

Hôpital du Haut Levêque - Dermatologie

Pessac, , France

Site Status

Centre Hospitalier Laennec - Dermatologie

Quimper, , France

Site Status

CHU Robert Debré

Reims, , France

Site Status

CHU Pontchaillou

Rennes, , France

Site Status

Cabinet de Dermatologie 43, rue Jean Lecanuet

Rouen, , France

Site Status

Hôpital Charles NICOLLE - Service de Dermatologie

Rouen, , France

Site Status

Le Royal Parc - Dermatologie

Saint-Brieuc, , France

Site Status

Centre Hospitalier Intercommunal Poissy Saint Germain

Saint-Germain-en-Laye, , France

Site Status

Cabinet de Dermatologie 1,rue dembarrère

Tarbes, , France

Site Status

Hôpital Beauregard

Thionville, , France

Site Status

CHU Trousseau - Dermatologie

Tours, , France

Site Status

Centre Hospitalier de Valence - Dermatologie

Valence, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23909381 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

02H37

Identifier Type: OTHER

Identifier Source: secondary_id

AOL02-DR-LOK

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Laser Therapy for Venous Leg Ulcers
NCT06135246 RECRUITING NA
PluroGel on Wounds of Mixed Etiology
NCT03275831 TERMINATED NA
Educational Interventions in Venous Leg Ulcer
NCT07031180 NOT_YET_RECRUITING NA