Improving the cost-effectiveness of therapeutic shoes for diabetic patients with a previous foot ulcer using an in-shoe pressure device

Conditions: diabetic polyneuropathy
pheripheral nerve damage due to type 2 diabetes
10034606

Registration Number: NL-OMON40191

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- Patients with diabetes (determined by a physician) with a history of a prior diabetic foot ulceration in the past 5 years, for whom a new pair of therapeutic footwear is prescribed by a physician.
- Patients who already have a pair of therapeutic footwear can be included as long as the production of a new pair of fully customized shoe wear is needed, according to the treating rehabilitation specialist.
- Diabetic neuropathy based on clinical examination performed by the researcher (defined as loss of Achilles tendon reflex combined with loss of protective sensation, i.e. loss of sensation of 10 g monofilament in at least 2 areas of each feet) after exclusion of other causes of neuropathy.
- Receiving regular preventive, podiatric, foot care in the diabetic foot clinic (at least 1x 3 months).
- Informed written consent.

Exclusion Criteria

- Severe peripheral arterial disease in one or both legs, i.e.: ABI < 0.5 or, in case of incompressible leg arteries during ABI measurement, absence of both foot pulses in one or two feet
- Not motivated for therapeutic footwear despite intensive education.
- Active foot ulcer or any pre-ulcerative lesion on either foot that according to the treating physician needs immediate specific off-loading measures (e.g. felt or debridement).
- Previous vascular intervention in one or both of the legs 3 months before inclusion
- End-stage renal disease (creatinin clearance < 20 ml/min or dialysis).
- Severe mobility impairment, i.e. not able to walk 100 meters without assistance.
- Any amputation more proximal than toe(s) amputation, except a single ray amputation is allowed, based on visual inspection.
- Severe visual impairment, i.e. not able to read a newspaper after correction.
- Active cancer.
- Severe cardiac or pulmonary failure (NYHA class 4), based on observation of symptoms at rest and the interview.
- Severe oedema that interferes with the efficacy of the prescribed therapeutic footwear, based on visual inspection.
- Chronic drug abuse.
- Severe psychiatric illness that would interfere with treatment or follow-up.
- Hospital admission at the time of inclusion.
- Any condition that according to the treating clinician or researcher would interfere with the follow-up visits.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint<br /><br>The cost-effectiveness of the WiS shoes and standard shoes, expressed as Euro*s/<br /><br>kPa plantar pressure reduction, calculated by determining:<br /><br>a) production costs of the therapeutic footwear (materials and manpower),<br /><br>b) the change in plantar peak pressure (measured with WalkinSense) at the area<br /><br>of previous ulceration during wearing the prescribed therapeutic footwear,<br /><br>calculated as peak plantar pressure in normal shoes minus in-shoe peak plantar<br /><br>pressures in the therapeutic shoes at the moment of final delivery of the shoes<br /><br>by the shoemaker </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>a) The change in peak plantar pressure at the area of previous ulceration after<br /><br>3 months wearing the prescribed therapeutic footwear of the WiS and<br /><br>Standard-shoes<br /><br>b) The change in the highest plantar peak pressure in the foot with a history<br /><br>of prior ulceration after 3 months of the WiS and Standard-shoes<br /><br>c) The number of new patients reported and visible shoe and/or diabetic foot<br /><br>problems (including foot ulcers) during the 3 months follow-up period while<br /><br>wearing the WiS or Standard-shoes<br /><br>d) Differences in production techniques, materials and procedures of the WiS<br /><br>and Standard-shoes<br /><br>e) Differences in plantar pressures measured with WalkinSense between the WiS<br /><br>and Standard-shoes<br /><br>f) The use and usability of the WiS-shoes compared to the Standard-shoes<br /><br>measured with the MOS (please see additional files)</p><br>