Evaluation of Footwear Fit Guidelines Under Pressure in At-Risk Feet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- During the procedure difference in the mean in-shoe PPP by ROI associated with each toe gap standard
研究概览
简要总结
One in five foot ulcers are caused by the footwear worn by people with diabetes, yet there is a lack of consensus around footwear fit. Recommended toe gaps (the gap between the longest toe and the inside of the shoe) vary depending on the footwear guidance referred to but no research to date has assessed the recommendations' effectiveness in minimising in-shoe pressures.
The investigators will carry out a pilot study in 60 people with diabetes and loss of foot sensation (neuropathy). In this study, the investigators will measure in-shoe pressures whilst participants walk at the same pace to the beat of a metronome. An insole placed inside participants' shoes will measure in-shoe pressures. Participants will wear the same (standardised) type of footwear. The study is designed to detect a difference in pressure within this made-to-measure footwear whose fit conforms to Standard 1 guidance compared with footwear whose fit conforms to Standard 2 guidance. Differences between Standards 1 and 2 with Standard 3 will be considered secondary analyses. Standards are simplified to three non-overlapping recommended toe gap ranges of 0.5-1.0cm; 1.5-2.0cm and 1.0-1.5cm.
The investigators will also analyse the heat images taken with a thermographic camera before and after walking in standardised footwear whose fit confirms to these standards (this is known as the plantar thermal stress response to walking). Footwear fit will be determined by measuring the dimensions of participants' feet and that of participants' footwear and comparing the two.
The investigators will also measure footwear fit and associated in-shoe pressure/plantar thermal stress response in participants' habitual footwear during walking at paced and self-selected speeds.
详细描述
The investigators will recruit 60 participants with diabetes, neuropathy and a history of ulceration. The investigators will set a minimum target recruitment number for each sex (25 minimum for each).
People with diabetes and neuropathy will be recruited through the Leicester General Hospital Multi-disciplinary Foot Team (MDFT). Leicestershire Partnership NHS Trust (LPT) will be used as a PIC site which runs 24 Community Podiatry clinics to identify possible participants. Our CODEC database (an ongoing trial looking at the effect of sleep patterns on blood glucose control) where participants agreed to be contacted regarding other studies will also be used to identify possible participants.
Participants who consent to participate in the study, will have foot measurements. These foot measurements taken at baseline are both relevant to footwear fit and necessary to order comfortable, custom fit standardised house shoes aimed at those with diabetes who are at risk. Those participants assigned to footwear fit Standards which are within the IWGDF recommended range of 1.0-2.0cm toe gap will also be permitted to retain their made-to-measure standardised footwear - a house shoe designed for people with diabetes with at-risk feet. Participants assigned footwear with a non-IWGDF compliant footwear fit (i.e. a short toe gap of less than 1.0cm) will not be permitted to retain their standardised footwear given uncertainty regarding their suitability for long-term use.
The air-conditioning will be switched on to control the ambient temperature. Participants will be asked to bring everyday (i.e. most frequently used) footwear or prescribed footwear.
Participants' habitual footwear will then be photographed by a member of the research team using a CE-marked digital camera and the footwear style, condition and materials are recorded by a researcher using the Footwear Assessment Form (FAF). Footwear fit will then be determined by measuring the internal length of the shoe using a special gauge and measuring internal shoe width using a calliper-type device. Heel height will also be measured using a ruler.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-80 years
- •Confirmed diagnosis of diabetes mellitus type 1 or type 2
- •Confirmed diagnosis of neuropathy;
- •Able to walk unaided for a minimum of 200 steps with capacity to attend the research site
- •PAR-Q physical activity questionnaire does not indicate any possible heart problems, dizziness or other issue indicating unsuitability for mild physical exercise involved in walking
- •Willingness and capacity to participate in the study and to sign the informed consent form
排除标准
- •Unconfirmed diabetes mellitus diagnosis
- •Inability to ambulate independently without walking aids
- •Presence of rheumatoid arthritis
- •Active ulcer (i.e. having an active ulcer at the time of recruitment)
- •Recently healed ulcer (an ulcer which has had less than six months to fully heal)
- •History of Charcot in foot/joints
- •Previous minor or major amputation
- •Neurological disorders other than diabetes-related neuropathy potentially affecting gait, balance or posture
- •Evidence of significant peripheral vascular disease e.g. (i) attendance at a specialist vascular clinic; (ii) documentation of occlusive arterial disease or intervention; (iii) at least one pulse should be palpable on the affected foot with exclusion where neither pulse is palpable
- •Blood pressure >180/100 or <90/50
- •Unable to understand written and verbal English
- •PAR-Q physical activity questionnaire indicates possible heart problems, dizziness or other issue indicating unsuitability for mild physical exercise involved in walking
结局指标
主要结局
During the procedure difference in the mean in-shoe PPP by ROI associated with each toe gap standard
时间窗: During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%
During the procedure Mean in-shoe peak plantar pressure (PPP) for each region of interest (ROI) (comprising 10 regions: hallux, toes 2/3, toes 4/5, metatarsal 1, metatarsal 2/3, metatarsal 4/5, medial midfoot, lateral midfoot, medial heel, lateral heel) associated with each toe gap standard during walking within standardised footwear at a regulated pace
During the procedure difference in mean in-shoe PPP associated with each toe gap standard within standardised footwear @ regulated pace
时间窗: During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%
During the procedure Difference in the mean average in-shoe peak plantar pressure (PPP) associated with each toe gap standard (measured by Pedar-X pressure monitoring insoles) during walking within standardised footwear at a regulated pace
次要结局
- During the procedure Pressure time integral & contact area associated with toe gap standards in standardised footwear(During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%)
- During the procedure Proportion of participants with in-shoe PPP > 200 kilopascals in habitual footwear(During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%)
- During the procedure PTSR associated with each toe gap standard in standardised footwear(Thermal image taken with FLIR T540-EST thermal camera of plantar surface of feet at rest and after 200 steps within standardised footwear)
- During the procedure Percentage of participants with incorrectly fitted / correctly fitted habitual footwear(At presentation on visit 2)
- During the procedure Exploratory secondary analysis of toe gap Standard 3 in relation to toe gap Standards 1 and 2(During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%)
- During the procedure Proportion of participants with in-shoe PPP > 200 kilopascals in standardised footwear(During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%)
- During the procedure Mean in-shoe PPP within habitual footwear at a self-selected and regulated pace(During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%)
- During the procedure Pressure time integral & contact area associated with toe gap standards in habitual footwear(During the procedure, pressure time integral and contact area is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%)
- During the procedure PTSR associated with habitual footwear(Thermal image taken with FLIR T540-EST thermal camera of plantar surface of feet at rest and after 200 steps within habitual footwear)