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

Category Primary study
Registry of TrialsANZCTR
Year 2013
INTERVENTION: 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. CONDITION: Chronic venous insufficiency Venous or mixed venous/arterial leg ulcer PRIMARY OUTCOME: The primary outcome is incidence of leg ulcer recurrence. ; ; 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) 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. ; 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. SECONDARY OUTCOME: Depression using the Geriatric Depression Scale Health related quality of life using the SF‐8 Physical activity levels and types of physical activity using the Yale Physical Activity Survey Range of ankle Motion using bi‐plane goniometry Self efficacy using the General Self‐Efficacy Scale Social support using the Medical Outcomes Study Social Support Scale between 0.6 and 1.2
Epistemonikos ID: 0b1041079105072e17aa3d610e5802d05d8c4877
First added on: Aug 25, 2024