Hallux ValgusNCT07378917
Orthotic Impact on MTP Alignment in Hallux Valgus
A study testing Hallux Valgus Orthosis in people with Hallux Valgus, run by University of Valencia at 1 site in Spain.
Trial summary
This study aims to evaluate the effectiveness of an external corrector in realigning the first metatarsophalangeal joint in patients with mild to moderate Hallux Abducto Valgus, according to the Manchester scale. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Hallux Valgus Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 22 Nov 2025to 27 Apr 2026
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex: Male or female Age: 18 to 80 years Cooperative subject, informed of the need and duration of follow-up visits, ensuring full compliance with the protocol/study, and having signed informed consent No previous surgery on the foot and/or ankle Mild and/or moderate Hallux Valgus (Manchester Scale)
Who cannot join
- Patient with severe arteriopathy Patient with severe edema Patient with sensory neuropathy Patients who have used additional pharmacological treatments (analgesics/anti-inflammatories) during the entire study period Severe Hallux Valgus (Manchester Scale) Any systemic disease affecting the musculoskeletal system Rheumatoid arthritis involving the first metatarsophalangeal joint Instability of the first metatarsophalangeal joint History of previous foot and/or ankle surgery Hyperpronated foot with FPI >10 Severe pathological genu varum or valgum Pregnant women or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Metatarsophalangeal Joint Alignment in Mild and Moderate Hallux Abducto Valgus Through Orthotic Intervention
This study aims to evaluate the effectiveness of an external corrector in realigning the first metatarsophalangeal joint in patients with mild to moderate Hallux Abducto Valgus, according to the Manchester scale. Changes in valgus angle will be assessed through radiographs, along with pain, comfort and adherence, comparing results with a control group.
Read the detailed description
Introduction and Rationale Hallux Abducto Valgus (HAV) is the most common forefoot deformity, often associated with pain and functional limitations. Its development is multifactorial, and although surgical and conservative treatments exist, evidence regarding the real effectiveness of corrective orthopedic devices in early stages is scarce. This study seeks to provide scientific rigor to a device frequently recommended in clinical practice by evaluating its ability to correct alignment and improve symptoms.
Main and Secondary Objectives The primary objective is to assess the effectiveness of the corrector in realigning the first toe by measuring the valgus angle radiographically at three time points: without the corrector, immediately after application, and after 3 months. Secondary objectives include evaluating pain (VAS), comfort, adherence, device fit, changes in plantar pressure (static and dynamic), patient satisfaction, and differences compared to the control group.
Study Design and Population This is an experimental study involving a group of 35 subjects diagnosed with mild or moderate HAV according to the Manchester scale, recruited at the Aquilesia podiatry clinic (Vila-real, Castelló). Recruitment will be carried out through local media, social networks, and referrals from healthcare professionals. Informed consent, anonymity, and compliance with data protection regulations will be ensured.
Intervention and Measurements The intervention consists of applying an external hallux alignment corrector. Three radiographic measurements of the metatarsophalangeal angle will be taken: baseline, after corrector placement, and at 3 months. Additional data will include pain, comfort, adherence and device adjustment. Standardized scales (VAS, satisfaction questionnaires) and Excel-based data recording will be used.
Data Processing and Analysis Data will be collected by a podiatrist and anonymized before analysis. Intra- and intergroup differences will be evaluated using appropriate statistical tests, considering variables such as sex, age, and degree of deformity. The study aims to determine whether the corrector produces significant improvements in alignment and other clinical parameters, providing evidence for its usefulness in podiatric practice.
- Conditions
- Hallux Valgus
- Being tested
- Hallux Valgus Orthosis
- Keywords
- Hallux Abducto Valgus (HAV), Metatarsophalangeal Joint Alignment, Orthotic Devices, Radiographic Assessment
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hallux Valgus OrthosisDevice
This study evaluates the effectiveness of an external hallux valgus orthosis in realigning the first metatarsophalangeal joint in patients with mild to moderate HAV. Two radiographic measurements of the valgus angle will be taken: at baseline and after 3 months of daily orthosis use. Participants will receive instructions for proper placement and adjustment. Secondary outcomes include pain (VAS), comfort, satisfaction, plantar pressure analysis (static/dynamic), device fit, and adherence. Data will be collected by podiatrists and anonymized for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Orthosis | Experimental | The study group will consist of 35 adult subjects, both men and women, diagnosed with mild to moderate Hallux Abducto Valgus (HAV) according to the Manchester scale. Receives: Device: Hallux Valgus Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Valgus Angle Correction
Measurement of the hallux valgus angle on digital radiographs at baseline and after 3 months of orthosis use, to determine the degree of realignment of the first metatarsophalangeal joint.
Measured: 3 months
Secondary outcomes (6)
Pain Assessment (VAS)
Evaluation of pain intensity in the hallux region using the Visual Analog Scale (0 = no pain, 10 = worst pain).
Measured: 3 months
Comfort and Satisfaction
Subjective assessment of comfort, aesthetics, and overall satisfaction with the orthosis through a structured questionnaire.
Comfort was evaluated using a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no comfort and 10 indicates maximum comfort.
Measured: 3 months
Device Fit and Adjustment
Evaluation of orthosis sizing and traction adjustment scored on a 1-10 scale, including ease of placement by the participant.
Measured: 1day
Orthosis Condition After Use
Assessment of wear and tear of the device after 3 months, scored on a 1-10 scale.
Measured: 3 months
Adherence to Treatment
Monitoring of daily orthosis use through self-reported logs and follow-up visits.
Measured: 3 months
Purchase Decision
Whether the participant would consider buying the orthosis after the study (Yes/No).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start22 Nov 2025
- Primary completion30 Mar 2026
- Study completion27 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARMEN GARCÍA GOMARIZ, University of Valencia
- Investigators
- CARMEN GARCÍA GOMARIZ, Principal investigator, UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378917
- Sponsor's protocol ID
- EJC_01
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metatarsophalangeal Joint Alignment in Mild and Moderate Hallux Abducto Valgus Through Orthotic Intervention
- ClinicalTrials.gov ID
- NCT07378917
- Acronym / sponsor ID
- EJC_01
- Conditions
- Hallux Valgus
- Keywords
- Hallux Abducto Valgus (HAV), Metatarsophalangeal Joint Alignment, Orthotic Devices, Radiographic Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 30 Jan 2026 (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.
This study aims to evaluate the effectiveness of an external corrector in realigning the first metatarsophalangeal joint in patients with mild to moderate Hallux Abducto Valgus, according to the Manchester scale. Changes in valgus angle will be assessed through radiographs, along with pain, comfort and adherence, comparing results with a control group.
Detailed description
Introduction and Rationale Hallux Abducto Valgus (HAV) is the most common forefoot deformity, often associated with pain and functional limitations. Its development is multifactorial, and although surgical and conservative treatments exist, evidence regarding the real effectiveness of corrective orthopedic devices in early stages is scarce. This study seeks to provide scientific rigor to a device frequently recommended in clinical practice by evaluating its ability to correct alignment and improve symptoms.
Main and Secondary Objectives The primary objective is to assess the effectiveness of the corrector in realigning the first toe by measuring the valgus angle radiographically at three time points: without the corrector, immediately after application, and after 3 months. Secondary objectives include evaluating pain (VAS), comfort, adherence, device fit, changes in plantar pressure (static and dynamic), patient satisfaction, and differences compared to the control group.
Study Design and Population This is an experimental study involving a group of 35 subjects diagnosed with mild or moderate HAV according to the Manchester scale, recruited at the Aquilesia podiatry clinic (Vila-real, Castelló). Recruitment will be carried out through local media, social networks, and referrals from healthcare professionals. Informed consent, anonymity, and compliance with data protection regulations will be ensured.
Intervention and Measurements The intervention consists of applying an external hallux alignment corrector. Three radiographic measurements of the metatarsophalangeal angle will be taken: baseline, after corrector placement, and at 3 months. Additional data will include pain, comfort, adherence and device adjustment. Standardized scales (VAS, satisfaction questionnaires) and Excel-based data recording will be used.
Data Processing and Analysis Data will be collected by a podiatrist and anonymized before analysis. Intra- and intergroup differences will be evaluated using appropriate statistical tests, considering variables such as sex, age, and degree of deformity. The study aims to determine whether the corrector produces significant improvements in alignment and other clinical parameters, providing evidence for its usefulness in podiatric practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthosis | Experimental | Device: Hallux Valgus OrthosisThe study group will consist of 35 adult subjects, both men and women, diagnosed with mild to moderate Hallux Abducto Valgus (HAV) according to the Manchester scale. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sex: Male or female Age: 18 to 80 years Cooperative subject, informed of the need and duration of follow-up visits, ensuring full compliance with the protocol/study, and having signed informed consent No previous surgery on the foot and/or ankle Mild and/or moderate Hallux Valgus (Manchester Scale)
Key exclusion criteria (1 listed)
- Patient with severe arteriopathy Patient with severe edema Patient with sensory neuropathy Patients who have used additional pharmacological treatments (analgesics/anti-inflammatories) during the entire study period Severe Hallux Valgus (Manchester Scale) Any systemic disease affecting the musculoskeletal system Rheumatoid arthritis involving the first metatarsophalangeal joint Instability of the first metatarsophalangeal joint History of previous foot and/or ankle surgery Hyperpronated foot with FPI >10 Severe pathological genu varum or valgum Pregnant women or suspected pregnancy
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 |
|---|---|---|
| Hallux Valgus OrthosisThis study evaluates the effectiveness of an external hallux valgus orthosis in realigning the first metatarsophalangeal joint in patients with mild to moderate HAV. Two radiographic measurements of the valgus angle will be taken: at baseline and after 3 months of daily orthosis use. Participants will receive instructions for proper placement and adjustment. Secondary outcomes include pain (VAS), comfort, satisfaction, plantar pressure analysis (static/dynamic), device fit, and adherence. Data will be collected by podiatrists and anonymized for analysis. | Device | Orthosis |
Primary outcome
Radiographic Valgus Angle Correction
Time frame: 3 months
Measurement of the hallux valgus angle on digital radiographs at baseline and after 3 months of orthosis use, to determine the degree of realignment of the first metatarsophalangeal joint.
6 secondary outcomes
Pain Assessment (VAS)
Time frame: 3 months
Comfort and Satisfaction
Time frame: 3 months
Device Fit and Adjustment
Time frame: 1day
Orthosis Condition After Use
Time frame: 3 months
Adherence to Treatment
Time frame: 3 months
Purchase Decision
Time frame: 3 months
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 28 Apr 2026.
- Individual participant dataSharing planned: No
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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.
CARMEN GARCÍA GOMARIZ principal investigator
UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hallux Valgus Orthosis in people with Hallux Valgus, run by University of Valencia 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 1 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 28 Apr 2026. 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?
Radiographic Valgus Angle Correction (time frame: 3 months). 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 28 Apr 2026.