Identifying effective new interventions to prevent recurrence of leg ulcers in adults with chronic venous insufficiency.

Not Applicable

Completed

• Conditions: Venous or mixed venous/arterial leg ulcer; Chronic venous insufficiency; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Physical Medicine / Rehabilitation - Physiotherapy; Skin - Other skin conditions

• Registration Number: ACTRN12613001017718
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

* Clients diagnosed with a leg ulcer of venous or mixed venous/arterial aetiology which has healed within the previous four weeks from recruitment

* The ulcer is completely healed (where healing is defined as full epithelialisation of the ulcer which has been maintained for at least two weeks without breakdown)

* Clients with an Ankle Brachial Pressure Index (ABPI)
between 0.6 and 1.2

Exclusion Criteria

* Clients who are unable to understand English

* Clients with a cognitive impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is incidence of leg ulcer recurrence.<br><br>Upon 3 monthly clinical assessment, i.e. a well leg check follow up appointments the participant is seen by a Nurse practitioner who performs a clinical examination. Participants will be advised to ring the clinic and make an appointment if they develop an ulcer recurrence between their regular appointments.<br>[3 months, 6 months, 9 months and 12 months after healing.]

Secondary Outcome Measures

Name	Time	Method
Physical activity levels and types of physical activity using the Yale Physical Activity Survey[Baseline and at 3, 6, 9, 12 months after healing.];Social support using the Medical Outcomes Study Social Support Scale [Baseline and at 3, 6, 9, 12 months after healing.];Range of ankle Motion using bi-plane goniometry[Baseline only];Depression using the Geriatric Depression Scale[Baseline and at 3, 6, 9, 12 months after healing.];Self efficacy using the General Self-Efficacy Scale [Baseline and at 3, 6, 9, 12 months after healing];Health related quality of life using the SF-8 [Baseline and at 3, 6, 9, 12 months after healing]