Improving the cost-effectiveness of therapeutic shoes for diabetic patients with a previous foot ulcer using an in-shoe pressure device - Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes

niversiteit Maastricht0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月29日

适应症

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•- 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.

•- 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.

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