A Feasibility Randomised Controlled Study to Examine the Effect of Otoform Toe Dividers in the Treatment of Patients With Diabetes Mellitus Following a Lesser Toe Amputation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Acceptibility of wearing a toe divider
研究概览
简要总结
Summary of study
The study will examine patients with Diabetes Mellitus (DM) who have had a lesser toe amputations (LTA) (toes 2nd3rd,4th or 5th). It is currently not understood how this affects the way patients walk and foot function. No previous studies have been undertaken to examine this and its potential for causing further ulceration risk.
This study is a feasibility study. It is designed to see if it is possible to undertake a large, randomised trial. It will explore how participants are recruited, kept in the study and how easy it is to follow the study protocol.
Aim of the study
Establish the feasibility of a corresponding full scale investigation into to the effectiveness of a toe divider made from Otoform for patients with DM following an LTA.
Study Design
- Participants will be recruited from Mid Yorkshire NHS teaching Hospital.
- Participants will be randomised to receive either standard care or an otoform toe divider.
- Participants age, gender, medical history, medication and blood sugar levels will be recorded.
- Vascular and neurological assessments, foot posture and toe deformities will be undertaken and recorded.
- All participants will have pressures measured on the plantar aspects of both feet.
- Follow up visits will be arranged every 6 weeks for12 months for all participants to monitor foot health and changes in walking pattern and pressure redistribution.
- If an ulceration or other foot complication occurs, the participants will be removed from the study and appropriate treatment given (the rescue arm of the study).
详细描述
The study is currently being undertaken in part fulfil a PhD and because the research questions have not previously been answered.
The main study questions are:
- Can a large scale randomised control trial been undertaken using the methodology of the feasibility study?
- How does gait and foot function change after an LTA in patients with DM?
- Does an Otoform toe divider improve foot function and affect pressure redistribution reducing the risk of ulcerations?
- Can the research learn how to research, write, execute and evaluate a feasibility study as part of her PhD?
There is no previous research examining the effects that DM and an LTA have on gait and foot structure or the use of toe dividers manufactured from otoform as a treatment following an LTA. It is not known why these patients are at risk of developing further ulcerations and where on the foot these are likely to be. It is known that up to 60% of patients who have DM and an LTA require further surgery including revision surgery, further minor amputations or major amputations. None of the studies that established this did not look at why. This study aims in part to answer this.
This subject area has also been selected as toe dividers are routinely given to patients and there is anecdotal evidence to support this but how effective they have not been studied. It has also been chosen as there are no current guidelines or recommendation on how to treat this patient group. An Otoform toe divider has been selected as it is the most used material from which toe dividers are made. This was established after a questionnaire was sent to health care workers involved in the care of patients with DM and LTA. The questionnaire asked what treatments were used and what materials were chosen and why. This questionnaire has fulfilled the first part of the researchers PhD. Further material testing at the University of Huddersfield's engineering department found that Otoform was more effective in dealing with compression and deformation forces than other materials commonly involved (silicone gel and semi compressed felt). The other two materials were found not to withstand these forces as well as Otoform. Semi compressed felt could also not be washed which created a hygiene issue.
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
- None
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants over the age of
- •Participants with DM and a lesser toe amputation.
- •Participants who wish to take part and provide informed written consent
- •Participants who are mobile (including those who use walking aids).
排除标准
- •Participants under the age of
- •Participants who do not have DM.
- •Participants who have active ulcerations or surgical sites.
- •Participants who had had a 1st toe and/or ray amputation.
- •Participants with neuroarthropathy or other marked foot deformities.
- •Participants who already wear a toe divider.
- •Participants who have a known allergy to the silicone or catalyst being used.
- •Participants who are immobile.
研究组 & 干预措施
Study Arm
The study group will be given a toe divider
干预措施: Otoform toe divider (Device)
Control Arm
Participants will continue to receive regular treatment.
结局指标
主要结局
Acceptibility of wearing a toe divider
时间窗: From enrollment and then every 6 weeks for 52 weeks.
theoretical frame work of acceptability questionnaire
次要结局
- Peak Pressure(From enrollment and then every 6 weeks for 52 weeks.)
- Contact Area(From enrollment and then every 6 weeks for 52 weeks.)
- Pressure time integral(From enrollment and then every 6 weeks for 52 weeks.)
- Foot Posture Index(From enrollment and then every 6 weeks for 52 weeks.)