Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Last updated: September 12, 2019
Sponsor: Region Örebro County
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcers

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT04085926
18RS6667
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with diabetes mellitus (any kind)

  • Foot ulcer under metatarsal heads

Exclusion

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 againstinfection 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 donot have appropriate social support, will be excluded.

Study Design

Total Participants: 150
Study Start date:
August 02, 2019
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Mölndahls sjukhus

    Gothenburg, SE-431 80
    Sweden

    Site Not Available

  • Skånes Universitetssjukhus, Malmö

    Malmö, SE-205 02
    Sweden

    Site Not Available

  • Örebro Universitetssjukhus

    Örebro, SE-70185
    Sweden

    Active - Recruiting

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