Diabetic FootNCT04085926
Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers
A study testing Sealed therapeutic shoe and Total contact cast in people with Diabetic Foot, run by Region Örebro County at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Sealed therapeutic shoe and Total contact cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesSweden
- Study dates
- 16 Jan 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with diabetes mellitus (any kind)
- Foot ulcer under metatarsal heads
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Mölndahls sjukhus
Gothenburg, SE-431 80
Skånes Universitetssjukhus, Malmö
Malmö, SE-205 02
Örebro Universitetssjukhus
Örebro, SE-70185
About this study
Official title: Sealed Therapeutic Shoe vs. Total Contact Cast as Treatment of Diabetic Foot Ulcers: a Multicenter RCT
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.
Read the 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.
- Conditions
- Diabetic Foot
- Being tested
- Sealed therapeutic shoe, Total contact cast
- Keywords
- Wound Healing, Casts, Surgical, Shoes
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sealed therapeutic shoeDevice
Off-the-shelf therapeutic shoe and custom-made insole
Total contact castDevice
Custom-made total contact cast
| Study group | Role | What they receive |
|---|---|---|
| Sealed shoe | Experimental | 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. Receives: Device: Sealed therapeutic shoe |
| Total contact cast | Active comparator | A irremovable custom-made total Contact cast enclosing the foot and shin Receives: Device: Total contact cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after treatment is initiated
Secondary outcomes (25)
Number of participants with skin complications through study completion (treatment period, on average 12 weeks)
abrasions, iatrogenic ulcers, blisters, etc.
Measured: Through study completion (treatment period, on average 12 weeks)
Average level of plasma glucose concentration, measured as glycated haemoglobin (HbA1c)
Blood sample of HbA1c
Measured: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Body mass index
weight (kg) divided by squared length (m)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 number of steps measured with ActivPAL activity monitor
Measured: 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 sitting measured with ActivPAL activity monitor
Measured: 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 laying measured with ActivPAL activity monitor
Measured: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Mean daily time spent standing measured with ActivPAL activity monitor
Mean daily time spent standing measured with ActivPAL activity monitor
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Ankle range of motion (dorsal flexion)
goniometer, standardized measurement method
Measured: Baseline, 1, 6, and 12 months after treatment end
Ankle strength (plantar and dorsal flexion)
dynamometer, standardized measurement method
Measured: 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.
Measured: Baseline, 1, 6, and 12 months after treatment end
Satisfaction with treatment measured with visual analogue scale
Score range 0-100 (higher is better)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1, 6 and 12 months after treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start16 Jan 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Why it stopped: Difficulties with recruting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Forte
- Responsible party
- Principal investigator, Gustav Jarl, Region Örebro County
- Investigators
- Gustav Jarl, PhD, Principal investigator, University Health Care Research Center, Region Örebro county
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085926
- Sponsor's protocol ID
- 18RS6667
- Status last verified
- May 2025
- First submitted
- 2 Sep 2019
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sealed Therapeutic Shoe vs. Total Contact Cast as Treatment of Diabetic Foot Ulcers: a Multicenter RCT
- ClinicalTrials.gov ID
- NCT04085926
- Acronym / sponsor ID
- 18RS6667
- Conditions
- Diabetic Foot
- Keywords
- Wound Healing, Casts, Surgical, Shoes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruting participants
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Forte
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sealed shoe | Experimental | Device: Sealed therapeutic shoeTherapeutic 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 | Active comparator | Device: Total contact castA irremovable custom-made total Contact cast enclosing the foot and shin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with diabetes mellitus (any kind)
- Foot ulcer under metatarsal heads
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sealed therapeutic shoeOff-the-shelf therapeutic shoe and custom-made insole | Device | Sealed shoe |
| Total contact castCustom-made total contact cast | Device | Total contact cast |
Primary outcome
Percentage of participants with healed foot ulcers at 12 weeks
Time frame: 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.
25 secondary outcomes
Number of participants with skin complications through study completion (treatment period, on average 12 weeks)
Time frame: Through study completion (treatment period, on average 12 weeks)
Average level of plasma glucose concentration, measured as glycated haemoglobin (HbA1c)
Time frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Body mass index
Time frame: 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 frame: 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 frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Mean score on Berg balance scale
Time frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Calf muscle atrophy measured as maximal calf circumference
Time frame: Baseline, 1, 6, and 12 months after treatment end
General quality of Life measured with Short form 36 (SF-36)
Time frame: 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)
Time frame: 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
Time frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Mean daily number of steps measured with ActivPAL activity monitor
Time frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Mean daily time spent sitting measured with ActivPAL activity monitor
Time frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Mean daily time spent laying measured with ActivPAL activity monitor
Time frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Mean daily time spent standing measured with ActivPAL activity monitor
Time frame: 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
Time frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Bone mass density in heel bone
Time frame: 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
Time frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Ankle range of motion (dorsal flexion)
Time frame: Baseline, 1, 6, and 12 months after treatment end
Ankle strength (plantar and dorsal flexion)
Time frame: 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
Time frame: Baseline, 1, 6, and 12 months after treatment end
Satisfaction with treatment measured with visual analogue scale
Time frame: 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
Time frame: 6 and 12 months after treatment end
Out-patient health care consumption per participant assessed with study-specific questionnaire and patient files
Time frame: 1, 6 and 12 months after treatment end
In-patient health care consumption per participant assessed with study-specific questionnaire and patient files
Time frame: 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
Time frame: 1, 6 and 12 months after treatment end
Results and safety
The study was stopped early (reason given: Difficulties with recruting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Jarl, PhD principal investigator
University Health Care Research Center, Region Örebro county
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sealed therapeutic shoe and Total contact cast in people with Diabetic Foot, run by Region Örebro County at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties with recruting participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with healed foot ulcers at 12 weeks (time frame: 12 weeks after treatment is initiated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.