Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Centre Hospitalier Universitaire, Amiens35 sites in 1 country104 target enrollmentJanuary 1, 2003

ConditionsLeg Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Leg Ulcer
Sponsor: Centre Hospitalier Universitaire, Amiens
Enrollment: 104
Locations: 35
Primary Endpoint: Healing or non-healing of venous leg ulcers at week 24
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2003

End Date

December 1, 2008

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire, Amiens

Responsible Party

Sponsor

Eligibility 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