Diabetic Foot
Conditions
Keywords
Wound Healing, Casts, Surgical, Shoes
Brief summary
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
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.
Interventions
DEVICESealed therapeutic shoe
Off-the-shelf therapeutic shoe and custom-made insole
DEVICETotal contact cast
Custom-made total contact cast
Sponsors
Forte
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with healed foot ulcers at 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with skin complications through study completion (treatment period, on average 12 weeks) | Through study completion (treatment period, on average 12 weeks) | abrasions, iatrogenic ulcers, blisters, etc. |
| 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 | Blood sample of HbA1c |
| Body mass index | Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end | weight (kg) divided by squared length (m) |
| Gait function assessed with 10 m Walk test, mean value | Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end | Time to complete test, longer time is worse |
| 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 | Time to complete test, longer time is worse |
| Mean score on Berg balance scale | Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end | Total sum score is used, range 0-56 (higher is better) |
| Calf muscle atrophy measured as maximal calf circumference | Baseline, 1, 6, and 12 months after treatment end | Average values (cm) are reported |
| 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 | Mean values, score range 0-100 (higher is better) |
| 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 | Mean values, score range 0-1 (higher is better) |
| 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 values, score range 29-145 (lower is better) |
| 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 number of steps measured with ActivPAL activity monitor |
| 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 sitting measured with ActivPAL activity monitor |
| 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 laying measured with ActivPAL activity monitor |
| Mean daily time spent standing 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 |
| 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 | 3 items (intense activity, moderate activity, sitting time), each with 7 response alternatives (higher score is better) |
| Bone mass density in heel bone | Baseline, 1, 6, and 12 months after treatment end | Dual-energy X-ray absorptiometry (DXA) of calcaneus |
| 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 | 2 items, analyzed separately, score range 1-5 per item (lower is better) |
| Ankle range of motion (dorsal flexion) | Baseline, 1, 6, and 12 months after treatment end | goniometer, standardized measurement method |
| Ankle strength (plantar and dorsal flexion) | Baseline, 1, 6, and 12 months after treatment end | dynamometer, standardized measurement method |
| 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 | The 2 questions assess using time: number of days/week (range 0-7) and number of hours/day (6 categories). Higher score is better. |
| Satisfaction with treatment measured with visual analogue scale | approx. 4 weeks into treatment and 1 month after treatment | Score range 0-100 (higher is better) |
| 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 | Foot complications include new ulcers, Charcot foot, amputation, etc. |
| Out-patient health care consumption per participant assessed with study-specific questionnaire and patient files | 1, 6 and 12 months after treatment end | 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. |
| In-patient health care consumption per participant assessed with study-specific questionnaire and patient files | 1, 6 and 12 months after treatment end | 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. |
| 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 | Data from self-report questionnaire and Swedish Social Insurance Agency's system to assess number of days on sick leave |
Countries
Sweden
Outcome results
None listed