Cost-utility of an Integrated Personalised Assistive Devices Approach to Reduce Foot Ulcer Recurrence in Diabetes (DIASSIST): a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 5
- 主要终点
- Adherence to wearing custom-made footwear (as the primary patient-related outcome)
研究概览
简要总结
Preventing foot ulcers in people with diabetes can reduce costs and increase quality of life. Despite availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesise that a multimodal approach incorporating a variety of orthotic interventions that matches an individual person's need can reduce ulcer recurrence with beneficial cost-effectiveness and cost-utility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus type 1 or 2
- •Age 18 years or above
- •Loss of protective sensation based on the presence of peripheral neuropathy
- •A healed plantar foot ulcer or foot amputation in the preceding 4 years until two weeks before study inclusion
- •In possession of custom-made orthopaedic shoes, defined as "Orthopaedic shoes type A" or "Orthopaedic shoes type B" , or Orthopaedic Provision in Regular Footwear (OVAC), according to the Dutch healthcare system
- •Ability to provide informed consent
排除标准
- •Foot ulcer or open amputation site(s)
- •Active Charcot's neuroarthropathy
- •Foot infection, based on criteria of the PEDIS classification
- •Amputation proximal to the metatarsal bones in both feet
- •Healed ulcer on the apex of digitus 2-5 as the only ulcer location in the past 4 years, as surgical intervention (flexor tenotomy) is a more likely and guideline-recommended treatment for such patients, rather than the multimodal care under investigation
- •Severe illness that would make 12-months survival unlikely, based on the clinical judgment by the physician
- •Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on clinical judgment
研究组 & 干预措施
Multimodal care
Multimodal personalised treatment
干预措施: Custom-made shoes: pressure-optimized (Device)
Multimodal care
Multimodal personalised treatment
干预措施: Custom-made indoor shoes: pressure optimized (Device)
Multimodal care
Multimodal personalised treatment
干预措施: Foot temperature monitoring (Device)
Multimodal care
Multimodal personalised treatment
干预措施: Education (Behavioral)
Usual care
Usual care as offered to high-risk patients as offered in the Netherlands
结局指标
主要结局
Adherence to wearing custom-made footwear (as the primary patient-related outcome)
时间窗: 12 months (full study period)
defined as the percentage of steps taken in prescribed footwear, calculated by combining physical activity and wearing time measurements
Foot ulcer recurrence during the 12-months follow-up (as the primary clinical outcome)
时间窗: 12 months (full study period)
defined as "a break of the skin of the foot that involves as a minimum the epidermis and part of the dermis, in a person who has a history of foot ulceration, irrespective of location and time since the previous foot ulcer", with the first ulcer in the study period recorded as primary outcome and percentage participants with ulcer recurrence on group level as primary outcome
Cost-utility (as the primary economic outcome)
时间窗: 12 months (full study period)
defined as the ratio between costs related to foot care and quality-adjusted life years, based on the health utilities associated with the scoring profiles on the EQ-5D-5L with Dutch reference scores
次要结局
- Costs related to foot care (from a societal and medical perspective)(12 months (full study period))
- Cost-effectiveness(12 months (full study period))
- Quality-adjusted life years(12 months (full study period))
- Plantar foot ulcer recurrence(12 months (full study period))
- Foot ulcer recurrence at three predefined high-risk locations(12 months (full study period))
研究者
Sicco Bus, PhD
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)