Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Height compensation will be made with cork or EVA (polyurethane + Ethylene Vinyl Acetate) depending the characteristics of the shoe. It will be made by the same orthophaedic technician. The prescription of the heigh of the lift will be made with the patient in a barefoot standing position, a calibre will be used to mark the femoro-tibial joint in both lower limbs in order to rule out the asymmetry. After this, the patient will shod the offloading device in the ulcerated feet and their conventional footwear in the other foot (with the use of their own foot orthosis). 5 millimeters splints will be added under the non affected footwear until the previous mark in both limbs been balanced. The difference in the heigh between limbs will be assessed measuring all the splints used previously
Diabetic foot Unit Complutense University
Madrid, Spain
RECRUITINGPercentage of diabetic foot ulcers healed
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
Time frame: 12 weeks
Percentage of diabetic foot ulcers healed
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
Time frame: 20 weeks
Adherence to offloading device
Two pedometer will be used (one inside the vendaje and the other into the offloading device)
Time frame: 3 days
Time to healing
Time in weeks of diabetic foot ulcer healing
Time frame: 30 weeks
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