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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02061059
Other study ID # 13-1-112.3
Secondary ID
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


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
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