Efficacy of a Self-managed Cooling Intervention for Pain and Physical Activity in Individuals With Recently Healed Chronic Venous Leg and Diabetic Foot Ulcers: A Randomized Controlled Trial.
Teresa J Kelechi, Martina Mueller, Mohan Madisetti and 1 others
PMID 35507774WHAT IT FOUND
Adding a cooling patch to compression, leg elevation, or therapeutic footwear did not reduce pain or increase physical activity in people with recently healed venous leg or diabetic foot ulcers.
Pain was low at baseline, and few completed 6-month activity questionnaires.
Key findings
01When added to compression, leg elevation, or therapeutic footwear, cooling patches did not significantly reduce pain severity or interference compared with placebo patches at 6 months.
02Physical activity measured by MET minutes per week did not differ significantly between cooling and placebo groups at 6 months, and few participants completed both baseline and 6-month follow-up.
03Average steps measured by accelerometer did not differ significantly between cooling and placebo groups over 6 months, although both venous leg ulcer groups showed minimal improvement.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The analysed groups were small: 15 and 28 participants for healed venous leg ulcers and 12 and 15 for healed diabetic foot ulcers, despite the paper stating 82 venous and 58 diabetic foot ulcer participants were consented. Few participants completed both baseline and 6-month physical activity questionnaires. Adherence to standard care was not accurately assessed, and the authors observed that many participants did not consistently wear compression stockings or therapeutic footwear. Pain was low at baseline, so there was little room to show reduction. The trial reported pain and physical activity as its primary outcomes here, not ulcer recurrence, even though the intervention was developed for recurrence prevention.
Declared interests
No funding source or conflict-of-interest declaration appears in the supplied text.
The easy way to misread this
Do not read this trial as showing that a cooling patch reduces pain or increases physical activity after ulcer healing. The primary pain and activity outcomes were not significantly different, and the authors' suggestion to use MUSTCOOL for venous disease is based on prior work, not on these null results.