The Pressure Relieving Capacity of Siliconepads Compared to Felted Foam to Relieve Caput Metatarsal 2 in a Population With Diabetes at High Risk of Foot Ulcerations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Plantar pressure reduction
研究概览
简要总结
To evaluate the clinical effectiveness of siliconepads and if they could be an alternative to felted foam used in offloading high risk pressure areas in the plantar forefoot region using plantar pressure measurements.
Also user experience will be evaluated which is an important criterion in the use of this new type of offloading. Comfort, convenience and functionality of both felted foam and siliconepads will be tested to evaluate if siliconepads are more appropriate then felted foam.
详细描述
People with diabetes mellitus (DM) experience increased pressure under the plantar surface of the foot because of morphological, muscular and sensory abnormalities.
One third of these people have deformed feet, usually due to diabetic neuropathy, which causes localized increases in plantar pressure, particularly on the plantar side of the forefoot, where the risk of foot ulcers is high.
Custom-made therapeutic shoes and arch supports are recommended and are part of standard care for patients with foot deformities and a history of ulceration. The pressure under a human foot can be measured using a technique called Pedobarography or plantar pressure measurement, which uses insole- or platform-based pressure and force systems.
Pedobarographic measurements quantify the vertical load experienced by the foot when walking barefoot or with footwear by measuring the pressure on the plantar side. This makes it possible to identify any functional abnormalities in the structure and function of the dynamic foot. Wearing shoes with or without arch supports was reported to reduce peak pressure by 17 to 52% compared to walking barefoot. Furthermore, proof-of-principle studies have shown that reducing peak pressure on the plantar surface to less than 200 kPa (or by at least 25%) halves the risk of ulcer recurrence in people with diabetes over an 18-month period.
Felted foam therapy is, in addition to insoles and shoes, a complementary conservative treatment that facilitates this pressure relief. Felt consists of compressed wool in various thicknesses that distributes the increased pressure over a larger surface area, thereby reducing the peak pressure at a specific point. The location of the peak pressure is then relieved by the felt with a recess at this zone, whereby the pressure is distributed over the surface.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes, Peripheral neuropathy, able to walk 5 minutes, able to sign informed consent
排除标准
- •No diabetes, No neuropathy, not able to walk without walking aid, not able to sign informed consent
结局指标
主要结局
Plantar pressure reduction
时间窗: 48 hours
Achieve a plantar pressure decrease of 25%, leading to less than 200kpa under the 2nd caput metatarsal region after wearing siliconepads in comparison to barefoot plantar pressure measurement at baseline and after 48 hours. Achieve a plantar pressure decrease of 25% or less then 200kpa in the 2nd caput metatarsal region after wearing felted foam in comparison to barefoot plantar pressure measurement at baseline and after 48 hours.
次要结局
未报告次要终点
研究者
DienstThoracaleEnVasculaireHeelkunde
Prof. Dr. Caren Randon
University Hospital, Ghent
