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Purpose: This randomized clinical trial tested the hypothesis that individuals with CVDs randomized to receive a cryotherapy (gel wrap) intervention (CI) will have, compared to those randomized to the usual care (UC) group: greater reduction in skin temperature (Tsk) and blood flow (BF), and increased venous refill time (VRT) (microcirculation measures).
Methods: Sixty participants (n = 30 per group) were randomized to receive one of two daily 30-minute interventions for four weeks. The CI group applied the gel wrap around the affected lower leg skin and elevated the legs on a special pillow each evening at bedtime. The UC group elevated the legs only. Both groups wore compression stockings during the day. Participants measured Tsk with an infrared thermometer immediately before and after the intervention, and then 12 hours later.
Analysis: Comparisons of demographics,Tsk, BF, and VRT were analyzed using descriptive statistics, t-tests or Wilcoxon signed ranks tests, logistic regression analyses, and mixed model analyses.
Findings: Fifty seven participants (n = 28 CI; n = 29 UC) completed the study. The mean age was 62 (± 12) years, 70% female, 50% African American, 42% Class III obesity. In the final adjusted model, there was a significant decrease in BF between the CI and UC groups (-4.7 [-9.0; -0.4], P = 0.032) and pain (1.5 [0.3; 2.7, P = 0.012) after four weeks. No significant differences were noted in Tsk or VRT.
Conclusion: Findings from this feasibility study suggest that cryotherapy improves blood flow by slowing movement within the microcirculation, providing an intermediate term therapy. Future studies will address safety outcomes, cryotherapy delivery modalities, and dosing with a larger sample.