Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

This study has been completed.
Sponsor:
Collaborators:
Institut de Recherches Internationales Servier
Société de Dermatologie Française
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01673412
First received: July 31, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Leg Ulcer
Other: Psychological tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Healing or non-healing of venous leg ulcers at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    Healing or non-healing of venous leg ulcers at week 24


Secondary Outcome Measures:
  • clinical characteristics [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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)

  • biologic characteristics [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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)

  • psychologic assessments [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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)

  • cognitive assessments [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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)

  • social assessment [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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)

  • affected-leg characteristics [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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)

  • venous leg ulcers inclusion characteristics [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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)

  • venous insufficiency treatment [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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)


Enrollment: 104
Study Start Date: January 2003
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673412

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

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01673412     History of Changes
Other Study ID Numbers: AOL02-DR-LOK, 02H37
Study First Received: July 31, 2012
Last Updated: August 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
venous leg ulcer healing prognostic factors

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014