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

NCT02061059 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-02-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

block 1

shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements

OTHER

block 2

shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements

OTHER

standard

patient wears shoes produced with standard method

OTHER

with measurements

patient wears shoes produced with plantar pressure measurements

Sponsors & Collaborators

  • Maastricht University

    lead OTHER

Principal Investigators

  • Nicolaas C Schaper, PhD, MD · Maastricht University Medical Center

  • Hans H Savelberg, PhD · Maastricht University

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061059 on ClinicalTrials.gov