Diabetic Foot, Foot Ankle Injuries, Orthopedic Disorder
Conditions
Keywords
Prevention, Therapeutic footwear, New technologies
Brief summary
Patients with diabetes at high risk of ulceration require a perfect fitting shoe to avoid high shear and pressure forces. Neuropathy skews sensory perceptions and can alter the proper selection of the therapeutic footwear. The aims of study were to evaluate the ability of high-risk patients with diabetes in remission to select the proper therapeutic footwear and to validate a novel 3D foot scanner app for selecting the proper fitting therapeutic footwear.
Detailed description
A Randomized Controlled Clinical Trial in 30 patients with a previous healed diabetic foot ulcer. After parallel randomization (1:1) patients will be enrolled into two different groups: 1. Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences; 2. Patients that will acquire a specific size and model according to result of a novel mobile app 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy). Validation of proper therapeutic footwear fitting will be performed by a specialized podiatrist after acquisition of shoes in both groups. Therapeutic Footwear will be recommended to change when following ill fitting reason been found: excessive length or tight, or compromise with toes
Interventions
OTHER3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).
The 3D foot scan becomes a movile app that recommends a specific size and model of therapeutic footwear according to the measurements
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* High risk patients according to the International Working Group Diabetic Foot Guidelines (IWGDF-risk 3). * Healed diabetic foot ulcer at the moment of inclusion. * Capability to walk autonomously without walking aids. * Diabetic Peripheral neuropathy.
Exclusion criteria
* Major amputation in the contralateral limb (below or above the knee).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure was the requirement of Therapeutic Footwear change after prescription because ill fitting. | 1 week | Validation of proper therapeutic footwear fitting was performed by a specialized podiatrist after acquisition of shoes in both groups. TF was recommended to change when following ill fitting reason were found: excessive length or tight, or compromise with toes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with an ulcer occurrence event | 1 month | Presence of a new o previous ulcer located in the foot in a patient with diabetes |
Countries
Spain
Outcome results
None listed