Diabetic Foot Clinical Trial
— SmartfittingOfficial title:
Clinical Efficacy of a 3D Foot Scanner App for the Fitting of Therapeutic Footwear in Persons With Diabetes in Remission: A Randomized and Controlled Clinical Trial.
NCT number | NCT05353114 |
Other study ID # | CT-042022 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 15, 2022 |
Est. completion date | July 15, 2022 |
Verified date | November 2022 |
Source | Universidad Complutense de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 15, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Spain | Clínica Universitaria de Podología de la Universidad Complutense de Madrid | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure was the requirement of Therapeutic Footwear change after prescription because ill fitting. | 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 | 1 week | |
Secondary | Number of participants with an ulcer occurrence event | Presence of a new o previous ulcer located in the foot in a patient with diabetes | 1 month |
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