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

NCT02061059 | Unknown

• 1 other identifier: 13-1-112.3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Diabetes Mellitus; Polyneuropathies

Outcome Measures

Primary Outcomes (1)

• The cost-effectiveness of shoes produced with and without plantar pressure measurements.

  approximately 10 weeks (at delivery of the shoes)

Secondary Outcomes (6)

• 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.

  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.

  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)

Study Arms (4)

group 1

OTHER

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; Other: standard

group 2

OTHER

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; Other: with measurements

group 3

OTHER

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: block 2; Other: standard

group 4

OTHER

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: block 2; Other: with measurements

Interventions

block 1 OTHER

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

group 1; group 2

block 2 OTHER

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

group 3; group 4

standard OTHER

patient wears shoes produced with standard method

group 1; group 3

with measurements OTHER

patient wears shoes produced with plantar pressure measurements

group 2; group 4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• any condition that may interfere with follow-up visits.

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (2)

Maastricht University

Maastricht, 6200MD, Netherlands

Location

Smeets Loopcomfort

Sittard, 6135 LE, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus; Polyneuropathies

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Nicolaas C Schaper, PhD, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Hans H Savelberg, PhD

  Maastricht University

  STUDY DIRECTOR

Central Study Contacts

Tom Melai, PhD

CONTACT

+31 43 3881398; tom.melai@MaastrichtUniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

NL (2)