Happier Feet- Disrupting the Vicious Cycle of Healthcare Decline in Diabetic Foot Ulceration Through Active Prevention: The Future of Self-managed Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Shear data
研究概览
简要总结
This study aims to design, develop, and evaluate a smart insole to predict the formation of diabetic foot ulcers (DFUs) in diabetic participants at risk of developing them. The study will be conducted in two phases, using mixed-method research and engaging both diabetic participants and NHS clinicians. In Phase 1, the user-centred design of the smart insole will be developed through focus groups and online questionnaires, and a preliminary safety evaluation of the insole will be conducted with healthy team members. In Phase 2, the insole will be tested, validated, and data will be collected through baseline visits, lab studies, and insole data collection with shape-changed (pressure off-loading) insoles. The study will be conducted by researchers from the University of Manchester and the University of Exeter. It will include 10 people with diabetes and 10 healthy controls in Phase 2.
详细描述
The tasks in this phase will be conducted by researchers from the University of Manchester and the University of Exeter. All tasks will be held at the University of Exeter.
Recruited participants will attend three sessions (tasks) on three non-consecutive days in the span of three months.
Participants will be identified either through participant identifying centres (e.g., Manchester diabetes clinic) or through direct contact from ad response. From these identified patients, lists will be screened by either general practitioners (for National Health Service (NHS) sites) or the University of Manchester and University o Exeter researchers (for direct contact) according to eligibility criteria. Eligible participants will be written to and invited to return a reply slip detailing whether they are interested in taking part. The return slips will contain all necessary details of the study, including participant information sheets. These must be given to eligible participants at least 48 hours before any planned interview sessions.
Eligible participants that return reply slips, or email the research team to say they are interested, will be contacted by phone by a researcher to clarify any questions they may have. The researcher will then notify the participant of the schedule for the sessions. On the arranged date, before the sessions, the participant will complete the consent process.
n = 20 (10 diabetic participants, 10 healthy similar controls)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of diabetes
- •At the risk of developing a DFU 2) Able to understand and communicate to safely participate [Brief Assessment of Capacity 3) to have a score at least 6/8 (UBACC)]Capacity to participate 4) capability to walk for 10 mins without rest 5) Be able to walk for 30 minutes with no pain, no walking aid, and take breaks if required.
- •Must have sensation on their feet 7) Able to walk without a walking aid or orthotic.
排除标准
- •Below 18 years old
- •Contradictions to walking and physical activity
- •Broken skin on the foot
- •Suffering from a skin condition such as severe eczema or skin allergies
- •Pain affecting the ability to walk.
- •Healthy participants
- •Inclusion Criteria:
- •Above 18 years old
- •Able to walk for 30 minutes with no pain, no walking aid, and taking breaks if required.
- •No contraindications to walking and physical activity
- •No broken skin on the foot
- •Do not suffer from a skin condition such as severe eczema or skin allergies.
- •Exclusion Criteria:
- •below 18 years old
- •Any movement disorder
- •Pain during the walk
- •Broken skin on the foot.
- •suffer from a skin condition such as severe eczema or skin allergies.
结局指标
主要结局
Shear data
时间窗: Participant visit is for 90 minutes and data collection is for the (15 minutes walk, 2 minutes and standing still for 5 minutes)
Shear data The primary outcome measure includes testing the reliability of the smart insole in collecting 1. Shear stress data (KPa) while walking at a self-selected speed on the treadmill for 15 minutes 2. walking on the floor for 2 minutes. 3. standing on the floor for 5 minutes.
次要结局
未报告次要终点