Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sealed Therapeutic Shoe vs. Total Contact Cast as Treatment of Diabetic Foot Ulcers: a Multicenter RCT

Conditions
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Diabetic Foot

Intervention / Treatment
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* Device: Sealed therapeutic shoe
* Device: Total contact cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with diabetes mellitus (any kind) Foot ulcer under metatarsal heads Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sealed shoe<br>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. | Device: Sealed therapeutic shoe<br>* Off-the-shelf therapeutic shoe and custom-made insole<br>|
| Active Comparator: Total contact cast<br>A irremovable custom-made total Contact cast enclosing the foot and shin | Device: Total contact cast<br>* Custom-made total contact cast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with healed foot ulcers at 12 weeks | 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. | 12 weeks after treatment is initiated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with skin complications through study completion (treatment period, on average 12 weeks) | abrasions, iatrogenic ulcers, blisters, etc. | Through study completion (treatment period, on average 12 weeks) | 
| Average level of plasma glucose concentration, measured as glycated haemoglobin (HbA1c) | Blood sample of HbA1c | Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end | 
| Body mass index | weight (kg) divided by squared length (m) | Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end | 
| Gait function assessed with 10 m Walk test, mean value | Time to complete test, longer time is worse | 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 | Time to complete test, longer time is worse | Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end | 
| Mean score on Berg balance scale | Total sum score is used, range 0-56 (higher is better) | Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end | 
| Calf muscle atrophy measured as maximal calf circumference | Average values (cm) are reported | Baseline, 1, 6, and 12 months after treatment end | 
| General quality of Life measured with Short form 36 (SF-36) | Mean values, score range 0-100 (higher is better) | 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) | Mean values, score range 0-1 (higher is better) | 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 | Mean values, score range 29-145 (lower is better) | 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 | 3 items (intense activity, moderate activity, sitting time), each with 7 response alternatives (higher score is better) | Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end | 
| Bone mass density in heel bone | Dual-energy X-ray absorptiometry (DXA) of calcaneus | 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 | 2 items, analyzed separately, score range 1-5 per item (lower is better) | Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end | 
| Ankle range of motion (dorsal flexion) | goniometer, standardized measurement method | Baseline, 1, 6, and 12 months after treatment end | 
| Ankle strength (plantar and dorsal flexion) | dynamometer, standardized measurement method | Baseline, 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 | The 2 questions assess using time: number of days/week (range 0-7) and number of hours/day (6 categories). Higher score is better. | Baseline, 1, 6, and 12 months after treatment end | 
| Satisfaction with treatment measured with visual analogue scale | Score range 0-100 (higher is better) | approx. 4 weeks into treatment and 1 month after treatment | 
| Number of new foot complications per study group after healing assessed with study-specific questionnaire and patient files | Foot complications include new ulcers, Charcot foot, amputation, etc. | 6 and 12 months after treatment end | 
| Out-patient health care consumption per participant assessed with study-specific questionnaire and patient files | Study-specific questionnaire with 5 items assessing number of visits (6 response categories, higher is worse) for 5 types of out-patient visits related to the foot ulcer. Patient files will also be used to assess the same variables. | 1, 6 and 12 months after treatment end | 
| In-patient health care consumption per participant assessed with study-specific questionnaire and patient files | Study-specific questionnaire where participants fill in each hospital admission (and time period) related to the foot ulcer. Also patient files will be used to assess the same variables. | 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 | Data from self-report questionnaire and Swedish Social Insurance Agency's system to assess number of days on sick leave | 1, 6 and 12 months after treatment end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Healing, Casts, Surgical, Shoes