一种新品牌的库存“糖尿病专用”鞋预防糖尿病足溃疡复发的有效性。一项前瞻性队列研究。
Effectiveness of a new brand of stock 'diabetic' shoes to protect against diabetic foot ulcer relapse. A prospective cohort study.
作者信息
Busch K, Chantelau E
机构信息
Diabetes-Fussambulanz, MNR-Klinik der Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.
出版信息
Diabet Med. 2003 Aug;20(8):665-9. doi: 10.1046/j.1464-5491.2003.01003.x.
AIMS
Diabetic patients with podopathy (diabetic foot syndrome) may need protective footwear, be it customized or industrially produced stock 'diabetic' shoes (SDS). The effectiveness of each type of 'diabetic' shoe needs to be proven clinically, e.g. in terms of prevention of foot ulceration. The following study assesses a new German SDS, the LucRo shoe, which consists of rocker-shaped walking sole, a standardized shock absorption insole, and soft uppers without stiff toe-caps. The LucRo SDS has been registered as a Medicinal Product according to the European Community Guideline 93/42/EC.
PATIENTS AND METHODS
A total of 92 high-risk diabetic patients (mean age 63 years, duration of diabetes 13 years) with healed foot ulcer were recruited prospectively over 31 months; 87 patients suffered from polyneuropathy, 24 patients had peripheral ischaemic vessel disease. One group of patients (n = 60) received the LucRo SDS and wore them, while the remaining patients (n = 32) did not receive the SDS and were forced to use their normal footwear. This allocation reflects the haphazard reimbursement policies of the individual patients' health insurance, and is in accordance with the current German legislation. The patients were followed up for up to 42 months until the first foot ulcer relapse, or the end of the study.
RESULTS
There were no differences between the groups concerning age, sex, type and duration of diabetes, prevalence of polyneuropathy and peripheral ischaemic vessel disease, frequency of foot care and mortality rate. The first year annual rate of foot ulcer relapse was significantly different between the groups: 60% without SDS vs. 15% with SDS. The overall cumulative ulcer-free survival was significantly greater with SDS (P < 0.0001, log rank test).
CONCLUSION
The LucRo stock 'diabetic' shoe appears effective in the prevention of foot re-ulceration in high-risk patients with diabetic podopathy.
目的
患有足部病变（糖尿病足综合征）的糖尿病患者可能需要保护性鞋具，无论是定制的还是工业生产的现成“糖尿病”鞋（SDS）。每种类型的“糖尿病”鞋的有效性都需要经过临床验证，例如在预防足部溃疡方面。以下研究评估了一种新型德国SDS——LucRo鞋，它由摇椅形鞋底、标准化减震鞋垫和无硬鞋头的柔软鞋面组成。根据欧洲共同体93/42/EC指南，LucRo SDS已被注册为药品。
患者与方法
在31个月内前瞻性招募了92例足部溃疡已愈合的高危糖尿病患者（平均年龄63岁，糖尿病病程13年）；87例患者患有多发性神经病变，24例患者患有外周缺血性血管疾病。一组患者（n = 60）接受LucRo SDS并穿着，其余患者（n = 32）未接受SDS，被迫使用他们的普通鞋具。这种分配反映了各患者医疗保险的随意报销政策，并且符合德国现行法律。对患者进行长达42个月的随访，直至首次足部溃疡复发或研究结束。
结果
两组在年龄、性别、糖尿病类型和病程、多发性神经病变和外周缺血性血管疾病的患病率、足部护理频率和死亡率方面没有差异。两组之间第一年足部溃疡复发的年发生率有显著差异：未使用SDS组为60%，使用SDS组为15%。使用SDS时总的无溃疡累积生存率显著更高（P < 0.0001，对数秩检验）。
结论
LucRo现成“糖尿病”鞋似乎对预防高危糖尿病足部病变患者的足部溃疡复发有效。
Zotero 插件