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Completed

NCT Number: NCT01673412

Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

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.

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Key information

Conditions

Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalo-Universitaire d'Amiens - Dermatologie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological tests

Other

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

Primary outcomes

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

    Time frame: week 24

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

Secondary outcomes

  1. clinical characteristics

    Time frame: 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)

  2. biologic characteristics

    Time frame: 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)

  3. psychologic assessments

    Time frame: 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)

  4. cognitive assessments

    Time frame: 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)

  5. social assessment

    Time frame: 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)

  6. affected-leg characteristics

    Time frame: 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)

  7. venous leg ulcers inclusion characteristics

    Time frame: 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)

  8. venous insufficiency treatment

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Institut de Recherches Internationales Servier
  • Société de Dermatologie Française

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Aug 28, 2012
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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