NCT04085926

Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Sealed Therapeutic Shoe vs. Total Contact Cast as Treatment of Diabetic Foot Ulcers: a Multicenter RCT

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Region Örebro County · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Sealed therapeutic shoe	Off-the-shelf therapeutic shoe and custom-made insole
DEVICE	Total contact cast	Custom-made total contact cast

Timeline

• Start date: 2020-01-16
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2019-09-11
• Last updated: 2025-05-31

Locations

3 sites across 1 country: Sweden