Factorial4VLU: Exercise or dilute hypochlorous acid for venous leg ulcers: a factorial randomised trial
Factorial4VLU: A 2 x 2 factorial randomised controlled trial of exercise or dilute hypochlorous acid for healing venous leg ulcers
University of Auckland
380 participants
Mar 5, 2020
Interventional
Conditions
Summary
Factorial4VLU is a 2 x 2 factorial randomised controlled trial with participants allocated to prescribed progressive resistance exercises plus walking at least 3 times per week or usual care advice and/or a hypochlorous acid wound solution or placebo. The factorial design allows us to test two inventions at once. The purpose of the study is to determine if a hypochlorous acid wound solution or an exercise regimen helps venous leg ulcer (VLU) healing. The primary outcome is the proportion of participants with a completely healed reference ulcer at 12 weeks. Approximately 380 participants will take part from five District Nursing Services; Auckland DHB, Counties Manukau DHB (South Auckland), Capital & Coast DHB (Wellington), the Nurse Maude Association (Christchurch), and the Southern DHB (Dunedin). Participants will all be treated with compression therapy (tight bandaging or hosiery for the lower leg) and will be allocated to one of four arms for adjuvant treatments: [1] Prescribed daily regimen of progressive resistance exercises along with walking for 30 minutes per day three days per week plus ulcer cleansing using dilute hypochlorous acid wound solution when ulcer dressings are changed; or [2] Prescribed daily regimen of progressive resistance exercises along with walking for 30 minutes per day three days per week plus ulcer cleansing using purified water when ulcer dressings are changed; or [3] Usual care advice plus ulcer cleansing using dilute hypochlorous acid wound solution when ulcer dressings are changed; or [4] Usual care advice therapy plus ulcer cleansing using purified water when ulcer dressing changed. Participants will have four visits over 6 months (screening, baseline, week 12 and week 24) from a research nurse who is a qualified community nurse with experience in leg ulcer care. The visits will be where the participant would normally receive a district nurse visit (i.e. home or a clinic). Each visit will take about 30-60 minutes. In between the research nurse visits, the district nurse will look after the participant’s leg ulcer care.
Eligibility
Inclusion Criteria1
- Aged 18 years or older, determined to have a VLU (clinical indications of venous ulceration, Ankle Brachial Index greater than or equal to 0.8, and other causative aetiologies ruled out), able to tolerate compression therapy, able to provide written informed consent, and able to walk safely independently (aids allowed).
Exclusion Criteria1
- Have hypersensitivity to hypopchlorous acid or sodium hypochlorite, have a fixed ankle joint, have VLU with current infection (may be eligible once infection cleared), have VLU with exposed bone or tendon, have history of rheumatoid arthritis or vasculitis, have uncontrolled diabetes (HbA1c > 100), have severe liver, heart, or renal failure, have severe peripheral arterial disease, have suspected or diagnosed skin malignancy associated with the leg ulcer, or have any other threat to safe participation.
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Interventions
Arm 1: Prescribed regimen of exercise plus dilute hypochlorous acid wound solution (0.003%HOCl). The prescribed regimen of progressive resistance exercise consists of daily lower leg exercises to increase calf muscle strength at least until ulcer healing (3 sets of seated exercises starting with 10 repetitions per set and increasing up to 25 repetitions per set, before progressing to standing two-legged exercises and then standing one-legged exercises) with the participants' body weight providing the resistance element. Participants progress to the next stage of exercise when they are comfortable with achieving the current step. The exercise regimen is supported with a participant resource book that demonstrates the exercises, includes goal setting (which will be assisted by trained research nurses) and an exercise diary. The prescribed regimen also includes a target of walking for 30 minutes each day, three days per week. The regimen is to be demonstrated one-to-one by the research nurses, who assist the participant with goal setting recorded in the participant diary. Participants will perform the exercise wherever they are comfortable e.g. their own home. Exercise adherence is recorded in a participant diary. The wound solution will be sprayed on the ulcer at each at each dressing change, the wound debrided as required, devitalised tissue and debris will be removed, and the the wound solution reapplied before the ulcer is redressed. Venous ulcers are typically redressed once per week, but maybe redressed more frequently as indicated. Dressings are usually changed by nurses, but can be changed by some self-managing patients if wearing compression hosiery or wraps. Arm 2: Prescribed regimen of exercise plus placebo wound solution (purified water). The prescribed regimen of progressive resistance exercise consists of daily lower leg exercises to increase calf muscle strength at least until ulcer healing (3 sets of seated exercises starting with 10 repetitions per set and increasing up to 25 repetitions per set, before progressing to standing two-legged exercises and then standing one-legged exercises) with the participants' body weight providing the resistance element. Participants progress to the next stage of exercise when they are comfortable with achieving the current step. The exercise regimen is supported with a participant resource book that demonstrates the exercises, includes goal setting (which will be assisted by trained research nurses) and an exercise diary. The prescribed regimen also includes a target of walking for 30 minutes each day, three days per week. The regimen is to be demonstrated one-to-one by the research nurses, who assist the participant with goal setting recorded in the participant diary. Participants will perform the exercise wherever they are comfortable e.g. their own home. Exercise adherence is recorded in a participant diary. The wound solution will be sprayed on the ulcer at each at each dressing change, the wound debrided as required, devitalised tissue and debris will be removed, and the the wound solution reapplied before the ulcer is redressed. Venous ulcers are typically redressed once per week, but maybe redressed more frequently as indicated. Dressings are usually changed by nurses, but can be changed by some self-managing patients if wearing compression hosiery or wraps.
Locations(1)
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ACTRN12620000116921