The Role of Various Environmental Factors on the Incidence, Severity and Recurrence of Diabetic Foot Ulcers (DFUs) in Adult Patients With Diabetes in England
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Established the role of tested environmental factors and lifestyle choices on the incidence, recurrence, and severity of diabetic foot ulcers in adults living with diabetes in England.
研究概览
简要总结
Diabetic foot ulcers (DFUs) pose a significant threat to the health and wellbeing of diabetic patients. Affecting around 1 in 10 people (NHS North West Coast Strategic Clinical Networks, 2017) regardless of a diabetes type they often result in a drastically worsened quality of life and can lead to severe consequences including leg amputations. This survey will help to understand what role various environmental factors have on the incidence, severity and recurrence of DFUs. Results from this study will help healthcare professionals as well as patients to better understand various factors involved in DFU prevalence. Moreover, this survey could help to appreciate whether a more holistic approach should be followed when assessing DFU risk and deciding on therapy. This study will be run across five sites in England between October 2023 and May 2024 and will involve a small pilot study (informal interview) and an anonymous, ten-minute questionnaire. Any adult with an ongoing or past DFU will be eligible. Participants will be asked about their job type, quality of life, diabetic therapy, comorbidities, and environmental factors questions. There will be an option for a follow-up questionnaire after 12 weeks to understand the healing process and changes to the quality of life following a DFU incident. Additionally, patients may consent to provide access to excerpts from their anonymized medical history details (prescribed medications) to better understand their diabetic and DFU history. This study will be run as part of an industrial, London Interdisciplinary Biosciences Consortium (LIDo) PhD project investigating the autologous platelet-rich plasma gel for diabetic foot ulcers (RAPID™ biodynamic haematogel) with King's College London as funded by the Biotechnology and Biological Sciences Research Council (BBSCR) and Biotherapy Services Ltd.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>18 years old)
- •Diagnosed with diabetes
- •Currently having or have had at least one diabetic foot ulcer incident in the past
- •Resident in England
- •Able to consent
排除标准
- •Not diagnosed with diabetes
- •Never had a DFU incident
- •Unable/refusing to consent
- •A non-English resident
结局指标
主要结局
Established the role of tested environmental factors and lifestyle choices on the incidence, recurrence, and severity of diabetic foot ulcers in adults living with diabetes in England.
时间窗: 9 months
Descriptive statistics used to characterise the study population. Logistic regression modelling of tested environmental factors to establish models quantifying the association between independent and dependent variables (DFU incidence, severity, recurrence). Identified main environmental factors that produce the highest probability of having a severe diabetic foot ulcer case (based on the answers to the EQ-5D-5L - a severe DFU incident would is predicted to influence mobility, self-care, pain levels, performance of usual activities and anxiety/depression.)
次要结局
- Quantified the associations between the other disease co-occurring with diabetes and the medications or therapies prescribed for them that may have an impact on diabetic foot ulcer incidence and severity.(9 months)
- Established changes to DFU status and quality of life over the 12 week follow up period.(9 months)