Dear Editor,
We read with interest the recent article by Teresa J. Kelechi and colleagues, which we highly appreciate as it is of great clinical significance to explore the effect of new measures to prevent the recurrence of lower extremity ulcers. In the field of prevention and treatment of lower extremity ulcers, the authors were concerned about cooling treatment to prevent recurrence of ulcers, which is a novel and worthy of discussion topic. This study was designed as a longitudinal randomized controlled trial conducted in a multicenter association, and the results have certain guiding significance. However, in our view, there are a few limitations and considerations of this study that hinder accurate interpretation of results.
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. Considering that these patients who participated in the study independently can operate computer Web sites, it indicates that they are patients with higher educational level or pay enough attention to their own conditions, while the real high-risk population of ulcer recurrence is elderly patients.1 Although patients screened through the Web site are more likely to participate in the whole study process, as stated in the article, they will prevent recurrence of ulcers in various ways in daily life by themselves, and cooling treatment is only an auxiliary measure included in the standard of care.2 It is difficult to determine the real prevention and control efficacy of cooling therapy based on the results of this study, which may require the authors to further optimize the research program.
Second, we found that the sample size of this study was gradually lost in the process of follow-up. With reference to similar literature,3 the judgment may have some influence on the study results. We raise this question here in the hope of providing a reference for Kelechi's team. In order to obtain more accurate and true results, the sample size can be increased in subsequent studies, and the sample missing and fault tolerance can be taken into account.
In the end, although this study showed a negative result in the recurrence rate of diabetic foot, the article still reported and analyzed the reasons according to the facts, indicating that the team is rigorous in scientific research and has a correct academic attitude, which is worthy of our learning. However, the reasons for the negative results have not been clearly clarified, but we express our understanding. After all, various factors may affect the recurrence of ulcer.4
Jia-Yu Wei, BS
Wuxi Medical School
Jiangnan University
Wuxi, China
Shi-Xin Li, BS
Thoracic Surgery
Guyuan People's Hospital
Guyuan, China
Guo-Zhong Lyu, PhD
Department of Burns and Plastic Surgery
Affiliated Hospital of Jiangnan University
Wuxi, China
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