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

Maastricht University

Status: Unknown

Conditions: Polyneuropathies; Diabetes Mellitus

Treatments: Other: block 2; Other: block 1; Other: standard; Other: with measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT02061059

13-1-112.3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 4 patient groups

group 1

Other group

Description:

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

Treatment:

Other: block 1

Other: standard

group 2

Other group

Description:

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

Treatment:

Other: block 1

Other: with measurements

group 3

Other group

Description:

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

Treatment:

Other: block 2

Other: standard

group 4

Other group

Description:

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

Treatment:

Other: with measurements

Other: block 2