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Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT04085926
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
Stiftelsen Promobila
FORTE
Information provided by (Responsible Party):
Gustav Jarl, 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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Device: Sealed therapeutic shoe Device: Total contact cast Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Sealed Therapeutic Shoe vs. Total Contact Cast as Treatment of Diabetic Foot Ulcers: a Multicenter RCT
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sealed 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.
Device: Sealed therapeutic shoe
Off-the-shelf therapeutic shoe and custom-made insole

Active Comparator: Total contact cast
A irremovable custom-made total Contact cast enclosing the foot and shin
Device: Total contact cast
Custom-made total contact cast




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    abrasions, iatrogenic ulcers, blisters, etc.

  2. 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 ]
    Blood sample of HbA1c

  3. Body mass index [ Time Frame: Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end ]
    weight (kg) divided by squared length (m)

  4. 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 ]
    Time to complete test, longer time is worse

  5. 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 ]
    Time to complete test, longer time is worse

  6. Mean score on Berg balance scale [ Time Frame: 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)

  7. Calf muscle atrophy measured as maximal calf circumference [ Time Frame: Baseline, 1, 6, and 12 months after treatment end ]
    Average values (cm) are reported

  8. 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 ]
    Mean values, score range 0-100 (higher is better)

  9. 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 ]
    Mean values, score range 0-1 (higher is better)

  10. 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 values, score range 29-145 (lower is better)

  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. 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 ]
    3 items (intense activity, moderate activity, sitting time), each with 7 response alternatives (higher score is better)

  16. Bone mass density in heel bone [ Time Frame: Baseline, 1, 6, and 12 months after treatment end ]
    Dual-energy X-ray absorptiometry (DXA) of calcaneus

  17. 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 ]
    2 items, analyzed separately, score range 1-5 per item (lower is better)

  18. Ankle range of motion (dorsal flexion) [ Time Frame: Baseline, 1, 6, and 12 months after treatment end ]
    goniometer, standardized measurement method

  19. Ankle strength (plantar and dorsal flexion) [ Time Frame: Baseline, 1, 6, and 12 months after treatment end ]
    dynamometer, standardized measurement method

  20. 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 ]
    The 2 questions assess using time: number of days/week (range 0-7) and number of hours/day (6 categories). Higher score is better.

  21. Satisfaction with treatment measured with visual analogue scale [ Time Frame: approx. 4 weeks into treatment and 1 month after treatment ]
    Score range 0-100 (higher is better)

  22. 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 ]
    Foot complications include new ulcers, Charcot foot, amputation, etc.

  23. 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 ]
    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.

  24. 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 ]
    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.

  25. 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 ]
    Data from self-report questionnaire and Swedish Social Insurance Agency's system to assess number of days on sick leave



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085926


Contacts
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Contact: Gustav Jarl, PhD +46-19-6025875 gustav.jarl@regionorebrolan.se

Locations
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Sweden
Mölndahls sjukhus Not yet recruiting
Gothenburg, Sweden, SE-431 80
Contact: Roy Tranberg, PhD         
Skånes Universitetssjukhus, Malmö Not yet recruiting
Malmö, Sweden, SE-205 02
Örebro Universitetssjukhus Recruiting
Örebro, Sweden, SE-70185
Contact: Gustav Jarl, PhD    +46196025875    gustav.jarl@regionorebrolan.se   
Sponsors and Collaborators
Region Örebro County
Stiftelsen Promobila
FORTE
Investigators
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Principal Investigator: Gustav Jarl, PhD University Health Care Research Center, Region Örebro county
  Study Documents (Full-Text)

Documents provided by Gustav Jarl, Region Örebro County:
Study Protocol  [PDF] September 9, 2019
Statistical Analysis Plan  [PDF] September 9, 2019


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Responsible Party: Gustav Jarl, Associate Professor, Certified Prosthetist and Orthotist, Region Örebro County
ClinicalTrials.gov Identifier: NCT04085926     History of Changes
Other Study ID Numbers: 18RS6667
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gustav Jarl, Region Örebro County:
Wound Healing
Casts, Surgical
Shoes
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Calpastatin
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action