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

February 11, 2014 updated by: Maastricht University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: approximately 10 weeks (at delivery of the shoes)
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.
Time Frame: approximately 22 weeks (at follow-up)
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.
Time Frame: approximately 22 weeks (at follow-up)
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.
Time Frame: approximately 10 weeks (at delivery of the 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.
Time Frame: approximately 10 weeks (at delivery of the shoes)
approximately 10 weeks (at delivery of the shoes)
The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes".
Time Frame: approximately 22 weeks (at follow-up)
approximately 22 weeks (at follow-up)
Differences in plantar pressures between the two shoes produced.
Time Frame: approximately 22 weeks (at follow-up)
approximately 22 weeks (at follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 13-1-112.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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