AzTrials
AzTrials

Leg UlcerNCT01673412

Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

A study testing Psychological tests in people with Leg Ulcer, run by Centre Hospitalier Universitaire, Amiens at 35 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Leg Ulcer
What is being tested?
Psychological tests
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
35 sitesFrance
Study dates
Jan 2003to Dec 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

France35 sites

  • Centre Hospitalo-Universitaire d'Amiens - Dermatologie

    Amiens, 80000

  • Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I

    Amiens, 80000

  • Hôpital Victor Dupouy - Dermatologie

    Argenteuil, 95100

  • Hôpital Saint Jacques - Dermatologie 1

    Besançon, 25030

  • CHU de Brest - Dermatologie

    Brest, 29609

  • CHU Clémenceau - Dermatologie

    Caen, 14033

  • Hôpitaux Civils de Colmar - Service de Dermatologie

    Colmar, 68024

  • CHU Bocage - Dermatologie

    Dijon, 21034

  • CHU Michallon - Dermatologie

    Grenoble, 38043

  • Hôpital C. Foix - Service de Gérontologie

    Ivry, 94205

  • Centre Hospitalier - Service de Médecine Interne

    Lens, 62307

  • Hôpital Robert Boulin - Dermatologie

    Libourne, 33500

  • Hôpital Claude Huriez - Clinique Dermatologique

    Lille, 59037

  • CHRU Dupuytren - Dermatologie

    Limoges, 87042

  • Hôpital Saint Philibert - Dermatologie

    Lomme, 59462

  • Hôpital d'Instruction des Armées Desgenettes

    Lyon, 69998

  • Hôpital Sainte Marguerite - Dermatologie

    Marseille, 13009

  • Hôpital SAint Charles - Dermatologie

    Montpellier, 34295

  • Hôpital Fournier

    Nancy, 54000

  • Hôpital Rothschild - Consultation de Dermatologie

    Paris, 75012

  • CHU Bichat - Service de Dermatologie

    Paris, 75018

  • Hôpital Saint Louis - Service de Dermatologie

    Paris, 75475

  • Hôpital Broussais - Rééducation Vasculaire

    Paris, 75674

  • Hôpital du Haut Levêque - Dermatologie

    Pessac, 33604

  • Centre Hospitalier Laennec - Dermatologie

    Quimper, 29107

  • CHU Robert Debré

    Reims, 51092

  • CHU Pontchaillou

    Rennes, 35033

  • Cabinet de Dermatologie 43, rue Jean Lecanuet

    Rouen, 76000

  • Hôpital Charles NICOLLE - Service de Dermatologie

    Rouen, 76031

  • Le Royal Parc - Dermatologie

    Saint-Brieuc, 22000

  • Centre Hospitalier Intercommunal Poissy Saint Germain

    Saint-Germain-en-Laye, 78100

  • Cabinet de Dermatologie 1,rue dembarrère

    Tarbes, 65000

  • Hôpital Beauregard

    Thionville, 57100

  • CHU Trousseau - Dermatologie

    Tours, 37044

  • Centre Hospitalier de Valence - Dermatologie

    Valence, 26000

Other trials in France

About this study

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.

Conditions
Leg Ulcer
Being tested
Psychological tests
Keywords
venous leg ulcer healing prognostic factors
Medical subject headings
Leg Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychological testsOther

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

Study groups in NCT01673412
Study groupRoleWhat they receive
interventional armExperimentalPsychological tests
Receives: Other: Psychological tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healing or non-healing of venous leg ulcers at week 24

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

    Measured: week 24

Secondary outcomes (8)

  1. 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)

    Measured: week 24

  2. 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)

    Measured: week 24

  3. 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)

    Measured: week 24

  4. 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)

    Measured: week 24

  5. 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)

    Measured: week 24

  6. 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)

    Measured: week 24

  7. 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)

    Measured: week 24

  8. 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)

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2012 (estimated)
  2. Study startJan 2003
  3. Primary completionJun 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01673412
Sponsor's protocol ID
AOL02-DR-LOK
Other IDs
02H37
Status last verified
Sep 2025
First submitted
31 Jul 2012
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23909381

Questions about this trial

What is this clinical trial studying?

A study testing Psychological tests in people with Leg Ulcer, run by Centre Hospitalier Universitaire, Amiens at 35 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healing or non-healing of venous leg ulcers at week 24 (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01673412, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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