Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Leg Ulcer Clinical Trial

Official title:

Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673412
• Other study ID #: AOL02-DR-LOK
• Secondary ID: 02H37
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: August 23, 2012
• Start date: January 2003
• Est. completion date: December 2008

Study information

• Verified date: August 2012
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalo-Universitaire d'Amiens - Dermatologie	Amiens
France	Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I	Amiens
France	Hôpital Victor Dupouy - Dermatologie	Argenteuil
France	Hôpital Saint Jacques - Dermatologie 1	Besançon
France	CHU de Brest - Dermatologie	Brest
France	CHU Clémenceau - Dermatologie	Caen
France	Hôpitaux Civils de Colmar - Service de Dermatologie	Colmar
France	CHU Bocage - Dermatologie	Dijon
France	CHU Michallon - Dermatologie	Grenoble
France	Hôpital C. Foix - Service de Gérontologie	Ivry
France	Centre Hospitalier - Service de Médecine Interne	Lens
France	Hôpital Robert Boulin - Dermatologie	Libourne
France	Hôpital Claude Huriez - Clinique Dermatologique	Lille
France	CHRU Dupuytren - Dermatologie	Limoges
France	Hôpital Saint Philibert - Dermatologie	Lomme
France	Hôpital d'Instruction des Armées Desgenettes	Lyon
France	Hôpital Sainte Marguerite - Dermatologie	Marseille
France	Hôpital SAint Charles - Dermatologie	Montpellier
France	Hôpital Fournier	Nancy
France	CHU Bichat - Service de Dermatologie	Paris
France	Hôpital Broussais - Rééducation Vasculaire	Paris
France	Hôpital Rothschild - Consultation de Dermatologie	Paris
France	Hôpital Saint Louis - Service de Dermatologie	Paris
France	Hôpital du Haut Levêque - Dermatologie	Pessac
France	Centre Hospitalier Laennec - Dermatologie	Quimper
France	CHU Robert Debré	Reims
France	CHU Pontchaillou	Rennes
France	Cabinet de Dermatologie 43, rue Jean Lecanuet	Rouen
France	Hôpital Charles NICOLLE - Service de Dermatologie	Rouen
France	Le Royal Parc - Dermatologie	Saint Brieuc
France	Centre Hospitalier Intercommunal Poissy Saint Germain	Saint Germain en Laye
France	Cabinet de Dermatologie 1,rue dembarrère	Tarbes
France	Hôpital Beauregard	Thionville
France	CHU Trousseau - Dermatologie	Tours
France	Centre Hospitalier de Valence - Dermatologie	Valence

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Institut de Recherches Internationales Servier, Société de Dermatologie Française

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing or non-healing of venous leg ulcers at week 24	Healing or non-healing of venous leg ulcers at week 24	week 24	No
Secondary	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)	week 24	No
Secondary	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)	week 24	No
Secondary	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)	week 24	No
Secondary	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)	week 24	No
Secondary	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)	week 24	No
Secondary	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)	week 24	No
Secondary	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)	week 24	No
Secondary	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)	week 24	No