Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-16

Study Completion Date

2022-02-01

Brief Summary

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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.

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Detailed Description

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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

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Sealed therapeutic shoe

Intervention Type DEVICE

Off-the-shelf therapeutic shoe and custom-made insole

Total contact cast

A irremovable custom-made total Contact cast enclosing the foot and shin

Group Type ACTIVE_COMPARATOR

Total contact cast

Intervention Type DEVICE

Custom-made total contact cast

Interventions

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Sealed therapeutic shoe

Off-the-shelf therapeutic shoe and custom-made insole

Intervention Type DEVICE

Total contact cast

Custom-made total contact cast

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No