Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes

Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device

The purpose of this study is determine whether the use of plantar pressure measurements in the production of customized therapeutic footwear for patients with diabetes and a history of foot ulceration results in lower production costs and more pressure relief, compared to the standard production. A secondary objective is to explore if a difference in durability can be observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes produced with and without plantar pressure measurements.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus; Polyneuropathies
• Intervention / Treatment: Other: block 1; Other: standard; Other: with measurements; Other: block 2

Detailed Description

For each patient two pairs of shoes will be produced by two shoemakers, one using plantar pressure measurements and one according current standard production procedures. The patient will wear one of these two pairs of shoes during a period of 3 months.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6200MD
    • Maastricht University
  • Sittard, Netherlands, 6135 LE
    • Smeets Loopcomfort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diabetes
• neuropathy
• prescription of therapeutic footwear
• diabetic foot ulcer in the last 5 years
• receiving regular preventive foot care
• written informed consent

Exclusion Criteria:

• peripheral arterial disease
• not motivated to wear therapeutic footwear
• active foot ulcer
• recent vascular intervention
• severe mobility impairment
• amputation more proximal than toes, except a single ray amputation is allowed.
• severe visual impairment
• active cancer
• severe cardiac/ pulmonary failure
• severe oedema
• chronic drug abuse
• severe psychiatric illness
• hospital admission at the time of inclusion
• any condition that may interfere with follow-up visits.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: group 1; group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements. group is assigned to "standard": wears shoes produced with standard procedure	Other: block 1; shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements; Other: standard; patient wears shoes produced with standard method
OTHER: group 2; group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements group is assigned to "with measurements": wears shoes produced with plantar pressure measurements	Other: block 1; shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements; Other: with measurements; patient wears shoes produced with plantar pressure measurements
OTHER: group 3; group is assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements group is assigned to "standard": wears shoes produced with standard procedure	Other: standard; patient wears shoes produced with standard method; Other: block 2; shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
OTHER: group 4; group assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements group is assigned to "with measurements": wears shoes produced with plantar pressure measurements	Other: with measurements; patient wears shoes produced with plantar pressure measurements; Other: block 2; shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The cost-effectiveness of shoes produced with and without plantar pressure measurements.	approximately 10 weeks (at delivery of the shoes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plantar pressure after wearing the therapeutic shoes for 3 months.		approximately 22 weeks (at follow-up)
The number of participants with reported and/ or visible new diabetic foot problems, such as ulcera or pre-ulcerative lesions.	The number of diabetic foot problems serves as an additional measure of the quality of the therapeutic shoes produced.	approximately 22 weeks (at follow-up)
Differences in production techniques, materials and procedures used by the two shoemakers to produce the two pair of shoes.	Qualitative measure of differences in production process of the shoes produced with or without plantar pressure measurements.	approximately 10 weeks (at delivery of the shoes)
Differences in plantar pressures between the two shoes produced.		approximately 10 weeks (at delivery of the shoes)
The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes".		approximately 22 weeks (at follow-up)
Differences in plantar pressures between the two shoes produced.		approximately 22 weeks (at follow-up)

Collaborators and Investigators

• Sponsor: Maastricht University
• Investigators: Principal Investigator: Nicolaas C Schaper, PhD, MD, Maastricht University Medical Center; Study Director: Hans H Savelberg, PhD, Maastricht University

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ANTICIPATED): April 1, 2015
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (ESTIMATE): February 12, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies
• Other Study ID Numbers: 13-1-112.3