Prevalence of the Appearance of Diabetic Ulcers in Patients With 3D Insole and LSCI.

Summary

Diabetes is a serious and chronic disease that affects more than 347 million people in the world. It is the leading cause of death by age and its prevalence is increasing annually throughout the world. Diabetes is a disorder that manifests itself with elevated blood glucose levels that may be the resultof a deficiency in insulin secretion or action, or a combination of both problems.

The "Diabetic foot" includes a number of syndromes in which the interaction of the loss of protective sensation by the presence of sensory neuropathy, the change in pressure points due to motor neuropathy, autonomic dysfunction and decreased Blood flow due to peripheral vascular disease can lead to the appearance of injuries or ulcers induced by minor traumas that go "unnoticed." This situation leads to significant morbidity and a high risk of amputation. It can be prevented with the application of prevention programs, based on the early detection of neuropathy, assessment of associated risk factors, along with the application of a structured program of education and treatment of risk factors.

PRIMARY OBJECTIVES: 1- Comparison of ulceration rates, decrease in amputation rates in the target population with intervention: LSCI, thermography and creation of personalized insoles versus the control group with assessment, treatment and follow-up, without the intervention of interest in the study. 2- Correlation between changes in perfusion and temperature detected in combination of LSCI and thermography to predict diabetic foot ulcers and the risk of having ulcers. Study Model: Parallel Assignment 1:1 . Patients with inclusion criteria and without exclusion criteria will be randomized into two groups with Randomization with sequence concealment, centralized in computer support. OxMaR (Oxford Minimization and Randomization) After signing the informed consent, the patients will be divided into two groups. Number of Arms 2 Masking: None (Open Label) A-GROUP WITH LSCI, 3D FOOT CREATOR FOLLOW UP B- GROUP WITHOUT LSCI, 3D FOOT CREATOR FOLLOW UP.

Conditions

• Diabete Type 2
• Diabetic Foot
• Neuropathy, Diabetic
• Vascular Disease, Peripheral
• Diabetic Foot Ulcer

Interventions

DIAGNOSTIC_TEST

LSCI

1. A technician delivers a service at the home of the 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:a-the piezoelectric insole that replaces missing pain sensation;b- Laser speckle contrast imaging technique (LSCI) that measures the blood flow;c- the multi points temperature device. 2. Data collected by the technician are sent via internet 3. 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; 4. Using the 3D model of the foot, the chiropodist uses a 3D Editor to design the 3D Model of the insole to enable the production of a tailored insole for the patient shoes 5. The final manufactured insole is then delivered to the patient; 6. A check survey is periodically carried out by the technician to scan the diabetic foot status progress

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

  collaborator OTHER

• Universidad Miguel Hernandez de Elche

  collaborator OTHER

• Esther Soler

  lead OTHER

Principal Investigators

• ESTHER SOLER, BSN · CGE

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2025-03-01

Completion

2025-04-01