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

Does the Venous Insufficiency Program of Leg exercise and/or elevation (VIP Legs) prevent the recurrence of leg ulcers in adults with chronic venous insufficiency?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001017718
Acronym
VIP Legs - Venous Insufficiency Program of Leg exercise and/or elevation
Enrollment
46
Registered
2013-09-12
Start date
2013-09-23
Completion date
2015-01-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Venous leg ulcers are difficult and costly to heal, and unfortunately after healing, up to 70% of the ulcers recur. This study aims to obtain data on the effectiveness of a Venous Insufficiency Program of Leg exercise and/or elevation (VIP Legs) on prevention of venous or mixed venous/arterial leg ulcer recurrence. A randomised controlled trial will determine the effectiveness of VIP Legs interventions on health, quality of life and prevention of recurrence. Participants will be randomised to one of 3 groups: the VIP Legs elevation program, the VIP Legs exercise and elevation program, or routine post-healing recommendations as per RCN evidence-based guidelines. Participants in each group will be assessed upon healing, then at 3 months, 6 months, 9 months and 12 months after healing. Expected outcomes include early information on the interventions' effectiveness to provide urgently needed evidence on effective preventive strategies for this population.

Interventions

Clients who are attending the QUT Wound Healing Service for treatment of a venous or mixed venous/arterial leg ulcers will be invited to participate once their ulcer is healed. Participation will involve: - filling in a 20 minute questionniare (with questions on physical activity and quality of life) on recruitment and again at 3 months, 6 months, 9 months and 12 months - randomisation to one of 3 follow-up groups: Group A will receive routine follow-up care as recommended by evidence based g

Clients who are attending the QUT Wound Healing Service for treatment of a venous or mixed venous/arterial leg ulcers will be invited to participate once their ulcer is healed. Participation will involve: - filling in a 20 minute questionniare (with questions on physical activity and quality of life) on recruitment and again at 3 months, 6 months, 9 months and 12 months - randomisation to one of 3 follow-up groups: Group A will receive routine follow-up care as recommended by evidence based guidelines (i.e. routine advice and information on strategies to prevent ulcer recurrence) and be asked to attend the clinic for a check up at at 3 months, 6 months, 9 months and 12 months after healing. Group B will also receive routine follow-up care as recommended by evidence based guidelines (i.e. routine advice and information on strategies to prevent ulcer recurrence) PLUS be given instruction, demonstration and information on the VIP Legs program of tailored lower limb exercises and leg elevation (for one hour/day); and asked to attend the clinic for a check up at 3 months, 6 months, 9 months and 12 months after healing. Group C will also receive routine follow-up care as recommended by evidence based guidelines (i.e. routine advice and information on strategies to prevent ulcer recurrence) PLUS they will be given instruction and information on the VIP Legs program of leg elevation (for one hour/day); and asked to attend the clinic for a check up at 3 months, 6 months, 9 months and 12 months after healing. At baseline a research nurse with experience in chronic venous insufficiency and trained by an exercise physiologist will go through the respective intervention booklets (group B and C) with each participant to ensure each participants has adequate understanding of the interventions. We expect this will require between 15-30 minutes of explanation and demonstration based on the individual participants needs at baseline. Participants undertake the intervention programs by themselves in their own home over the intervention period. Participants that are randomised to the VIP Legs program of leg elevation are encouraged to put their legs up at home at their convenience at a time that suits them, for a total of one hour/day. Participants who are randomised to the VIP Legs program of lower leg exercises plus leg elevation will undertake the 1 hour of leg elevation per day and their tailored program of heel raises and walking for approximately 10-30 minutes/day at home. The exercises include stretching, heel raises, and walking. There is no additional equipment that is required by those participants randomised to the exercise group. All of the exercises are individualised and progressive based on the capacity of the individual performing them. The concept of progression is one of self-management that is thoroughly described in the exercise booklet given. Therefore the participant increases the amount of sets / repetitions of heel raises before progressing to the next stage of difficulty. Therefore all participants start with being recommended to perform 10 repetitions, 3 sets, 3 times / day of seated heel raises until they can perform these comfortably for 3 days in a row. The difference between Group B and Group C is that Group B are given a specific program of lower leg exercises (heel raises and walking) in addition to 1 hour/day of leg elevation; whereas Group C are only asked to do the 1 hour/day of leg elevation. Individuals that are randomised into Group B or C both receive a diary booklet that requires them to complete daily time allocated to their respective intervention, i.e. time spent elevating legs or time spent performing lower limb exercises or both. At baseline participants are advised they will be required to bring their dairies to their follow up well leg check appointment to hand into the clinic nurse.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026