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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02061059
• Other study ID #: 13-1-112.3
• Status: Not yet recruiting
• Phase: N/A
• First received: February 10, 2014
• Last updated: February 11, 2014
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2014
• Source: Maastricht University
• Contact: Tom Melai, PhD
• Phone: +31 43 3881398
• Email: tom.melai[@]MaastrichtUniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Polyneuropathies

Intervention

Other:
• block 1
shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements
• block 2
shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
• standard
patient wears shoes produced with standard method
• with measurements
patient wears shoes produced with plantar pressure measurements

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht
Netherlands	Smeets Loopcomfort	Sittard

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cost-effectiveness of shoes produced with and without plantar pressure measurements.		approximately 10 weeks (at delivery of the shoes)	No
Secondary	Change in plantar pressure after wearing the therapeutic shoes for 3 months.		approximately 22 weeks (at follow-up)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Differences in plantar pressures between the two shoes produced.		approximately 10 weeks (at delivery of the shoes)	No
Secondary	The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes".		approximately 22 weeks (at follow-up)	No
Secondary	Differences in plantar pressures between the two shoes produced.		approximately 22 weeks (at follow-up)	No