Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Conditions
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Leg Ulcer

Intervention / Treatment
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* Other: Psychological tests


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional arm<br>Psychological tests | Other: Psychological tests<br>* social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing or non-healing of venous leg ulcers at week 24 | Healing or non-healing of venous leg ulcers at week 24 | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous leg ulcer healing prognostic factors