Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

September 16, 2025 updated by: Centre Hospitalier Universitaire, Amiens
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hôpital 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Healing or non-healing of venous leg ulcers at week 24
Time Frame: week 24
Healing or non-healing of venous leg ulcers at week 24
week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
clinical characteristics
Time Frame: 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)
week 24
biologic characteristics
Time Frame: 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)
week 24
psychologic assessments
Time Frame: 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)
week 24
cognitive assessments
Time Frame: 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)
week 24
social assessment
Time Frame: 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)
week 24
affected-leg characteristics
Time Frame: 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)
week 24
venous leg ulcers inclusion characteristics
Time Frame: 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)
week 24
venous insufficiency treatment
Time Frame: 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)
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire, Amiens

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Société de Dermatologie Française
Institut de Recherches Internationales Servier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine LOK, PhD, Centre Hospitalo-Universitaire d'Amiens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2012

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AOL02-DR-LOK
  • 02H37 (Other Identifier: CPP Nord-Ouest II)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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