Clinical Trial: Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire, Amiens

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire, Amiens

Dates:
Date Received: July 31, 2012
Date Started: January 2003
Date Completion:
Last Updated: August 23, 2012
Last Verified: August 2012