Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01673412
• Date of registration: 31/07/2012
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier Universitaire, Amiens
• Public title: Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers
• Scientific title: Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers
• Date of first enrolment: January 2003
• Target sample size: 104
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01673412
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Catherine LOK, PhD
• Affiliation: Centre Hospitalo-Universitaire d'Amiens

Key inclusion & exclusion criteria

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



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Leg Ulcer

Intervention(s)

Other: Psychological tests

Primary Outcome(s)

Healing or non-healing of venous leg ulcers at week 24 [Time Frame: week 24]

Secondary Outcome(s)

biologic characteristics [Time Frame: week 24]

clinical characteristics [Time Frame: week 24]

affected-leg characteristics [Time Frame: week 24]

cognitive assessments [Time Frame: week 24]

psychologic assessments [Time Frame: week 24]

venous insufficiency treatment [Time Frame: week 24]

social assessment [Time Frame: week 24]

venous leg ulcers inclusion characteristics [Time Frame: week 24]

Secondary ID(s)

AOL02-DR-LOK

02H37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institut de Recherches Internationales Servier

Société de Dermatologie Française