Diabetic FootSmartfittingNCT05353114
Clinical Efficacy of a 3D Foot Scanner for the Therapeutic Footwear Fitting
A study testing 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy). in people with Diabetic Foot and Orthopedic Disorder, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Orthopedic Disorder, Foot Ankle Injuries
- What is being tested?
- 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Major amputation in the contralateral limb (below or above the knee).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Madrid, 28040
About this study
Official 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.
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.
Read the 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:
- Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences;
- 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
- Conditions
- Diabetic Foot, Orthopedic Disorder, Foot Ankle Injuries
- Being tested
- 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).
- Keywords
- Prevention, Therapeutic footwear, New technologies
- Medical subject headings
- Diabetic Foot, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).Other
The 3D foot scan becomes a movile app that recommends a specific size and model of therapeutic footwear according to the measurements
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapeutic Footwear prescription group | No intervention | 1) Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences |
| Therapeutic Footwear prescription based on a 3D Foot scanner | Experimental | 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). Receives: Other: 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (1)
Number of participants with an ulcer occurrence event
Presence of a new o previous ulcer located in the foot in a patient with diabetes
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start15 Jun 2022
- Primary completion30 Jun 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luis Lazaro Martinez, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353114
- Sponsor's protocol ID
- CT-042022
- Acronym
- Smartfitting
- Status last verified
- Nov 2022
- First submitted
- 22 Apr 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05353114
- Acronym / sponsor ID
- Smartfitting / CT-042022
- Conditions
- Diabetic Foot, Orthopedic Disorder, Foot Ankle Injuries
- Keywords
- Prevention, Therapeutic footwear, New technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences;
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapeutic Footwear prescription group | No intervention | –1) Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences |
| Therapeutic Footwear prescription based on a 3D Foot scanner | Experimental | Other: 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Major amputation in the contralateral limb (below or above the knee).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D 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 | Other | Therapeutic Footwear prescription based on a 3D Foot scanner |
Primary outcome
The primary outcome measure was the requirement of Therapeutic Footwear change after prescription because ill fitting.
Time frame: 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
1 secondary outcome
Number of participants with an ulcer occurrence event
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy). in people with Diabetic Foot and Orthopedic Disorder, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure was the requirement of Therapeutic Footwear change after prescription because ill fitting. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.