Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Not Applicable

Recruiting

• Conditions: Diabetic Foot
• Interventions: Device: Sealed therapeutic shoe; Device: Total contact cast

• Registration Number: NCT04085926
• Lead Sponsor: Region Örebro County

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.

Study Timeline

• Study Start: 2019-08-02
• Status Verified: 2019-09
• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-16
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sealed shoe	Sealed therapeutic 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.
Total contact cast	Total contact cast	A irremovable custom-made total Contact cast enclosing the foot and shin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Mean daily time spent standing measured with ActivPAL activity monitor	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	Dual-energy X-ray absorptiometry (DXA) of calcaneus
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.
Body mass index	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end	weight (kg) divided by squared length (m)
Mean daily number of steps measured with ActivPAL activity monitor	Baseline, approx. 4 weeks into treatment, 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	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.
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
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
Mean daily time spent laying measured with ActivPAL activity monitor	Baseline, approx. 4 weeks into treatment, 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	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
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 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 time spent sitting 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	3 items (intense activity, moderate activity, sitting time), each with 7 response alternatives (higher score is better)
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.
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.
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
Ankle strength (plantar and dorsal flexion)	Baseline, 1, 6, and 12 months after treatment end	dynamometer, standardized measurement method
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)
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.

Trial Locations

Locations (3)

Mölndahls sjukhus; 🇸🇪 Gothenburg, Sweden

Skånes Universitetssjukhus, Malmö; 🇸🇪 Malmö, Sweden

Örebro Universitetssjukhus; 🇸🇪 Örebro, Sweden