Purpose:The study aimed to evaluate the influence of a self-administered cooling intervention on quality of life (QOL) associated with chronic venous disease (CVD), stages clinical, etiological, anatomical, pathophysiological (CEAP) C4 (skin damage) and C5 (healed ulcer). Study design and subjects: A sample of 276 individuals was randomized to receive a cooling (n=138) or placebo control cuff (n=138) applied to the leg skin affected by CVD. Both groups also received standard of care that included compression, leg elevation, and physical activity. QOL was measured with the venous insufficiency epidemiological and economic study (VEINES)-QOL and symptom (Sym) subscale Questionnaire at 5 time points during the 9-month study. Relationships between treatment outcomes and demographics were analyzed. Results: Cooling and control groups had significant increases from baseline in mean change VEINES-QOL scores (13.5 vs 12.8, p<0.0001) and Sym scores (10.4 vs 6.7, p<0.0001). No significant difference was observed for VEINES-QOL between the groups (Δ =0.67, p=0.58); however, the difference was significant for Sym for cooling (Δ =3.7, p=0.015). Overall QOL improvements were significant for females compared to males (p<0.001), not employed fulltime (p<0.001), living in rural areas (p<0.002), and less effective for larger calf circumference (p=0.042). For age groups ≥65 years, cooling produced significant improvements in QOL (10.8 vs 4.5, p<0.0004); the control group symptoms worsened during the study (-1.0 vs 8.1, p<0.0001). Conclusion: This cooling intervention improved QOL. The greatest improvements were observed in older individuals, females, those who were married, not working full time, and living in rural areas. CVD remains a poorly controlled chronic condition and has a major negative influence on QOL. Keywords: chronic venous disease, quality of life, cooling therapy, negative symptoms, cryotherapy, venous disorders
Plain language summaryThe purpose of this study was to determine whether quality of life (QOL) was affected by the use of a cooling cuff to reduce negative symptoms of chronic venous disease (CVD) of the lower legs where the skin was previously ulcerated and/or damaged. Individuals participating in the study received one of two treatments: a cooling cuff made of gel or a "placebo" cuff filled with cotton. The cuffs were kept in the freezer until they were ready to be applied to the affected skin, starting daily for 30 minutes for 30 days, then twice-weekly for 3 months and then weekly for 3 months. Participants also wore compression hosiery during the day and elevated their legs each evening during the treatment. The VEINES Sym/QOL Questionnaire was used to measure QOL. We found that QOL improved in individuals using the cooling cuff compared to those using the cotton cuff; symptoms become worse in the latter group. Greater improvements were reported by females and those 65 years of age and older. Females and those older in age may be more positively susceptible to the effects of cooling to reduce negative...