Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Region Örebro County4 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks after treatment is initiated

Secondary Outcomes

Number of participants with skin complications through study completion (treatment period, on average 12 weeks)

abrasions, iatrogenic ulcers, blisters, etc.

Time frame: Through study completion (treatment period, on average 12 weeks)

Average level of plasma glucose concentration, measured as glycated haemoglobin (HbA1c)

Blood sample of HbA1c