Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Pustulosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- Percentage reduction of treated areas from baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a special sock, manufactured using TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar pustulosis present for at least one year.
详细描述
The clinical manifestations of palmoplantar pustulosis have an important impact on well being and quality of life. The manifestation of the disease is often exacerbated by factors such as significant physical and mechanical stress resulting from repeated and prolonged pressure over the affected areas and by everyday clothing. These problems have led the textile industry Lenzi Egisto S.p.A. to conduct some preliminary analyses to find a fabric that meets the specific needs of psoriatic patients in relation to everyday clothing. This preliminary study led to the creation of a particular fabric, TEPSO®, with features specific to the identified needs. This material consists essentially of PTFE (commercially known as Teflon®) and thus presents interesting characteristics that make it suitable for creating garments for patients with psoriasis:
- Excellent flow properties and low surface friction
- non-stick
- Complete biocompatibility and chemical inertness
We can therefore speculate that in palmoplantar pustulosis high smoothness of the fabric and low coefficient of friction may translate into less discomfort felt by patients during normal physical activities, and into improved clinical course of the disease. In the end, it is expected that reduced mechanical compression and friction, would result into partial or complete clinical remission within a few weeks of use.
Therefore we propose to conduct a randomized controlled, double-blind, left-right clinical trial to assess the hypothesis that in palmoplantar pustulosis the use of TEPSO® could induce an improvement of disease and overall quality of life. To better assess the effects of treatment, the use of clothing in the study will be limited to symmetrical pustular lesions of feet in order to include areas that are comparable and relevant from a functional point of view.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Palmoplantar pustulosis present for at least one year
- •Symmetrical foot lesions with at least 5% of the skin surface involvement
- •Difference less than or equal to 10% extension of lesions on both sides of the body
- •Suspension for over 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporine, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)
排除标准
- •Nonsymmetrical foot lesions or less than 5% of the skin surface involvement
- •Difference of more than 10% extension of lesions on both sides of the body
- •Patients who have performed, within 3 months before inclusion in the study, treatments with systemic drugs for psoriasis, immunosuppressive treatments (cyclosporine, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)
研究组 & 干预措施
TEPSO socks
This arm include all patients sides (left or right) treated with TEPSO socks.
干预措施: TEPSO cloth (Device)
Standard socks
This arm include all patients sides (left or right) treated with standard cotton socks.
干预措施: Standard cloth (Device)
结局指标
主要结局
Percentage reduction of treated areas from baseline
时间窗: 4 weeks
Percentage reduction is based on standardized photos and computerized image evaluation
次要结局
- Quality of life(4 weeks)
