Prevalence of the Appearance of Diabetic Ulcers in Patients With 3D Insole and LSCI. (MYFOOT-C)
Diabete Type 2, Diabetic Foot, Neuropathy, Diabetic
About this trial
This is an interventional prevention trial for Diabete Type 2 focused on measuring Diabete Type 2, Diabetic Foot, Neuropathy, Diabetic, Vascular Disease, Peripheral, Diabetic Foot Ulcer
Eligibility Criteria
Inclusion Criteria: The sample will include all the people who sign the informed consent. Patients aged between 18 and 80 years. Patients diagnosed with Diabetes Mellitus (more than 5 years from diagnosis), from the Department of Health Elche Hospital General. Patients with Risk Level 2 and 3 according to the International Working Group on the Diabetic Foot - IWGDF. Exclusion Criteria: People who do not give their consent to participate in the study. Patients who have previously had treatment with plantar orthoses or personalice insole.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Group with Laser speckle contrast imaging technique (LSCI) and 3D foot creator use
Group not use laser speckle contrast imaging technique (LSCI) and not use 3D foot creator use
The proposed solution is based on the process synthetized in, and hereafter described: A technician delivers a service at the home of the diabetic patient, who may be subject to different risk of ulcer, with the aim to analyse his/her foot through an integrated set of measurement technologies, based on: the piezoelectric insole that replaces missing pain sensation; Laser speckle contrast imaging technique (LSCI) that measures the blood flow; the multi points temperature device. Data collected by the technician are sent via internet to the reference Hospital or Primary Care Unit where a specialist physician evaluates the acquired information; On the basis of the clinical evaluation and doctor's report on points of foot sensitivity, a 3D model of the foot is created and used by the chiropodist; Using the 3D model of the foot, the chiropodist uses a 3D Editor to design the 3D Model of the insole
The patients of this group will be visited in the hospital: An assessment of the patient's risk of presenting problems due to diabetic foot will be carried out. In this group, the control measures will be established within the usual practice in consultations. No visits will be made to the patient's home. You will always visit the doctor's office. If any problem is detected, the patient will be visited by health personnel and the usual treatments in these patients at present will be applied.