Leg Ulcer
Conditions
Keywords
venous leg ulcer healing prognostic factors
Brief 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.
Interventions
OTHERPsychological tests
social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status
Sponsors
Institut de Recherches Internationales Servier
Société de Dermatologie Française
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing or non-healing of venous leg ulcers at week 24 | week 24 | Healing or non-healing of venous leg ulcers at week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| biologic characteristics | 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) |
| psychologic assessments | 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) |
| cognitive assessments | 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) |
| clinical characteristics | 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) |
| affected-leg characteristics | 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) |
| venous leg ulcers inclusion characteristics | 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) |
| venous insufficiency treatment | 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) |
| social assessment | 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) |
Countries
France
Outcome results
None listed