Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Leg Ulcer

Treatments: Other: Psychological tests

Study type: Interventional

Funder types: Other

Identifiers

NCT01673412

02H37 (Other Identifier)

AOL02-DR-LOK

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

104 participants in 1 patient group

interventional arm

Experimental group

Description:

Psychological tests

Treatment:

Other: Psychological tests