Sealed Therapeutic Shoe vs. Total Contact Cast as Treatment of Diabetic Foot Ulcers: a Multicenter RCT
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- Percentage of participants with healed foot ulcers at 12 weeks
研究概览
简要总结
Total contact casts (TCCs) are effective treatment of plantar diabetic foot ulcers because they effectively offload the ulcer and are non-removable, resulting in high adherence to using the device. However, TCCs are not widely used in clinical practice because they negatively impact gait and daily activities. A new treatment concept was invented, sealed therapeutic shoe, where a shoe with a custom-made insole offloads the ulcer, and the shoe is rendered irremovable to be worn day and night, like a TCC.
In this multicenter randomized controlled trial (RCT), 150 participants will be recruited and randomized to two treatment arms: TCC or sealed therapeutic shoe. The primary outcome is ulcer healing, secondary outcomes include (but are not limited to) skin complications, glycemic control, body mass index, gait function, balance, quality of life, physical activity, and health economics.
详细描述
Data for the primary outcome of 112 participants are needed but the aim is to recruit 150, if possible within a reasonable time frame, to take drop-out into account.
Participants are randomized (blocked randomization, stratified for ulcer site and study center) to either treatment with a sealed therapeutic shoe or total contact cast.
Each participant will be assessed by a cast technician during the treatment period (for ulcer healing and skin complications) and be assessed by a physiotherapist on five occasions: at baseline, approximately 4 weeks into treatment and 1, 6 and 12 months after treatment end. On these occasions the physiotherapist will perform different tests (gait, balance, ankle strength and flexibility, bone mass density in heel bone, etc) and participants will answer questionnaires and have their physical activity measured for 7 days with an activity monitor.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The primary outcome (ulcer healing) will be assessed by a cast technician not blinded to group allocation, but it will be verified from a photograph by a blinded assessor. The statistician comparing the primary outcome between groups will be blinded to group allocation.
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
- •Diagnosed with diabetes mellitus (any kind)
- •Foot ulcer under metatarsal heads
排除标准
- •large ulcer (3-5 metatarsal heads)
- •critical ischemia (defined as toe pressure <30 mmHg or TcPO2 <30 mmHg)
- •uncontrolled infection (IWGDF infection grade 4, or grade 3 if not treatment against infection has been administered)
- •Active Charcot foot
- •foot deformities that necessitate custom-made shoes
- •inability to speak/read Swedish.
- •People with increased risk that side-effects will not be discovered or reported (dementia, abuse of alcohol or drugs, intellectual disability, etc.) if the person do not have appropriate social support, will be excluded.
研究组 & 干预措施
Sealed shoe
Therapeutic footwear including off-the-shelf therapeutic shoes and custom-made insoles. The shoe on the ulcerated foot is "sealed", i.e., made irremovable, with a plastic band.
干预措施: Sealed therapeutic shoe (Device)
Total contact cast
A irremovable custom-made total Contact cast enclosing the foot and shin
干预措施: Total contact cast (Device)
结局指标
主要结局
Percentage of participants with healed foot ulcers at 12 weeks
时间窗: 12 weeks after treatment is initiated
Defined as complete epithelization, verified on a second occasion at least 14 days later. Primary outcome measure is proportion of ulcers healed in each Group after 12 weeks of treatment.
次要结局
- Ankle range of motion (dorsal flexion)(Baseline, 1, 6, and 12 months after treatment end)
- Ankle strength (plantar and dorsal flexion)(Baseline, 1, 6, and 12 months after treatment end)
- Satisfaction with treatment measured with visual analogue scale(approx. 4 weeks into treatment and 1 month after treatment)
- Number of participants with skin complications through study completion (treatment period, on average 12 weeks)(Through study completion (treatment period, on average 12 weeks))
- Average level of plasma glucose concentration, measured as glycated haemoglobin (HbA1c)(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Body mass index(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Gait function assessed with 10 m Walk test, mean value(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Gait function assessed with Timed up and go test, mean value(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Mean score on Berg balance scale(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Calf muscle atrophy measured as maximal calf circumference(Baseline, 1, 6, and 12 months after treatment end)
- General quality of Life measured with Short form 36 (SF-36)(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- General quality of Life measured with Euroqol 5 dimension 5 levels (EQ-5D-5L)(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Disease-specific quality of life measured with Diabetic foot ulcer scale -short form(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Mean daily number of steps measured with ActivPAL activity monitor(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Mean daily time spent sitting measured with ActivPAL activity monitor(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Mean daily time spent laying measured with ActivPAL activity monitor(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Mean daily time spent standing measured with ActivPAL activity monitor(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Physical activity measured with the Swedish National Board of Health and Welfare's indicator questions(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Bone mass density in heel bone(Baseline, 1, 6, and 12 months after treatment end)
- Internal locus of control measured with two items from Form C of the Multidimensional Health Locus of Control (MHLC-C) scale(Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end)
- Adherence to using therapeutic footwear assessed with 2 self-report questions adapted from the Questionnaire for persons with a transfemoral amputation(Baseline, 1, 6, and 12 months after treatment end)
- Number of new foot complications per study group after healing assessed with study-specific questionnaire and patient files(6 and 12 months after treatment end)
- Out-patient health care consumption per participant assessed with study-specific questionnaire and patient files(1, 6 and 12 months after treatment end)
- In-patient health care consumption per participant assessed with study-specific questionnaire and patient files(1, 6 and 12 months after treatment end)
- Sick-leave from work (number of days per participant) during treatment period (average 12 weeks) and during the period after treatment end up to 12 months later, assessed with study-specific questionnaire and Swedish Social Insurance Agency's system data(1, 6 and 12 months after treatment end)
研究者
Gustav Jarl
Associate Professor, Certified Prosthetist and Orthotist
Region Örebro County