Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

NCT04085926 | Terminated

• 1 other identifier: 18RS6667
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetic Foot

Keywords

Wound Healing; Casts, Surgical; Shoes

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after treatment is initiated

Secondary Outcomes (25)

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

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

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

  Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end

• Body mass index

  Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end

• Gait function assessed with 10 m Walk test, mean value

  Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end

• Gait function assessed with Timed up and go test, mean value

  Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end

Study Arms (2)

Sealed shoe

EXPERIMENTAL

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

Total contact cast

ACTIVE COMPARATOR

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

Device: Total contact cast

Interventions

Sealed therapeutic shoe DEVICE

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

Sealed shoe

Total contact cast DEVICE

Custom-made total contact cast

Total contact cast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with diabetes mellitus (any kind)
• Foot ulcer under metatarsal heads

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Örebro County: lead
• Forte: collaborator

Study Sites (3)

Mölndahls sjukhus

Gothenburg, SE-431 80, Sweden

Location

Skånes Universitetssjukhus, Malmö

Malmo, SE-205 02, Sweden

Location

Örebro Universitetssjukhus

Örebro, SE-70185, Sweden

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Gustav Jarl, PhD

  University Health Care Research Center, Region Örebro county

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Certified Prosthetist and Orthotist

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 11, 2019
• Study Start: January 16, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)