We wish to thank Guo-Zhong Lyu, Jia-Yu Wei, and Shi-Xin Li for taking the time to respond to our article, "Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial," published in the May/June 48(3) of the Journal of Wound, Ostomy and Continence Nursing.

Dr Lyu and colleagues point out "First of all, the target population was recruited through preliminary screening on the research Web site in this study, and we believe that patients prescreened in this way are not representative." We used the Web site method of recruitment, as one of many, to prescreen potentially eligible participants. The Web site was available for individuals with ulcers and/or their family members who had access to the Internet and were searching for research opportunities. In the United States, in 2021, 75% of individuals 65 years or older and 96% between 50 and 64 years of age use the Internet1; however, we recognize this figure varies by factors such as the availability of broadband, income, and rural versus nonrural residence. As such, we attempted to offer flexibility in how we recruited and prescreened for eligibility. Only 2.0% (5/246) of potentially eligible participants used this mechanism; the majority (53.3%; 131/246) were referred by their primary or health care providers. The patients then contacted the study team via the study phone number.

Regarding "Cooling treatment used as an auxiliary measure.... It is difficult to determine the real prevention and control efficacy of cooling therapy," in our previous randomized controlled trial,2,3 we controlled for standard of care in both the intervention treatment and placebo groups by providing participants with compression wraps, leg elevation pillows, and exercise and skin care regimens, in addition to the cooling and placebo devices. In the study reported here, we provided the cooling and placebo devices only; participants were instructed to resume self-management care to prevent ulcer recurrence based on what their health care provider instructed them to do (ie, obtain/wear appropriate footwear and compression stockings, elevate legs and feet, etc). This was intended to mimic "real-world" conditions. At baseline and final data collection visits, we asked for and documented the provider recommendations and what participants did and the frequency to determine adherence. A manuscript is currently in preparation to report these findings in which we will comment on efficacy, with consideration of the types and frequency of prevention strategies.

Also noted by Dr Lyu and colleagues, "The sample size can be increased in subsequent studies ... the reasons for the negative results have not been clearly clarified." We agree that the sample size was small due to interruption of recruitment at several of our clinical sites and that findings should be interpreted with caution and should be confirmed in future larger, adequately powered studies. However, development of a new ulcer and reoccurrence of a previously healed ulcer were considered study endpoints rather than uninformative study dropouts.

We appreciate your thoughtful comments and ideas, the supplied references, and believe these will add to future manuscripts and strengthen our future research.

Sincerely,

Teresa Kelechi, PhD, RN, FAAN

REFERENCES