Clinical trial NCT04085926: Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers
Official title: Sealed Therapeutic Shoe vs. Total Contact Cast as Treatment of Diabetic Foot Ulcers: a Multicenter RCT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot
Keywords: Wound Healing
Casts, Surgical
Shoes
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Forte
First posted: 2019-09-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with healed foot ulcers at 12 weeks
timeFrame: 12 weeks after treatment is initiated
Secondary outcomes:
measure: Number of participants with skin complications through study completion (treatment period, on average 12 weeks)
timeFrame: Through study completion (treatment period, on average 12 weeks)
measure: Average level of plasma glucose concentration, measured as glycated haemoglobin (HbA1c)
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Body mass index
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Gait function assessed with 10 m Walk test, mean value
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Gait function assessed with Timed up and go test, mean value
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Mean score on Berg balance scale
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Calf muscle atrophy measured as maximal calf circumference
timeFrame: Baseline, 1, 6, and 12 months after treatment end
measure: General quality of Life measured with Short form 36 (SF-36)
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: General quality of Life measured with Euroqol 5 dimension 5 levels (EQ-5D-5L)
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Disease-specific quality of life measured with Diabetic foot ulcer scale -short form
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Mean daily number of steps measured with ActivPAL activity monitor
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Mean daily time spent sitting measured with ActivPAL activity monitor
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Mean daily time spent laying measured with ActivPAL activity monitor
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Mean daily time spent standing measured with ActivPAL activity monitor
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Physical activity measured with the Swedish National Board of Health and Welfare's indicator questions
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Bone mass density in heel bone
timeFrame: Baseline, 1, 6, and 12 months after treatment end
measure: Internal locus of control measured with two items from Form C of the Multidimensional Health Locus of Control (MHLC-C) scale
timeFrame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
measure: Ankle range of motion (dorsal flexion)
timeFrame: Baseline, 1, 6, and 12 months after treatment end
measure: Ankle strength (plantar and dorsal flexion)
timeFrame: Baseline, 1, 6, and 12 months after treatment end
measure: Adherence to using therapeutic footwear assessed with 2 self-report questions adapted from the Questionnaire for persons with a transfemoral amputation
timeFrame: Baseline, 1, 6, and 12 months after treatment end
measure: Satisfaction with treatment measured with visual analogue scale
timeFrame: approx. 4 weeks into treatment and 1 month after treatment
measure: Number of new foot complications per study group after healing assessed with study-specific questionnaire and patient files
timeFrame: 6 and 12 months after treatment end
measure: Out-patient health care consumption per participant assessed with study-specific questionnaire and patient files
timeFrame: 1, 6 and 12 months after treatment end
measure: In-patient health care consumption per participant assessed with study-specific questionnaire and patient files
timeFrame: 1, 6 and 12 months after treatment end
measure: 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
timeFrame: 1, 6 and 12 months after treatment end
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Mölndahls sjukhus
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus, Malmö
city: Örebro
country: Sweden
facility: Örebro Universitetssjukhus
Study officials:
affiliation: University Health Care Research Center, Region Örebro county
name: Gustav Jarl, PhD
role: PRINCIPAL_INVESTIGATOR
References: