MetatarsalgiaIMEDESCALNCT06534073
Baropodometric Patterns Associated With Metatarsalgia
A study testing Socks, Standard device and Foot orthoses in people with Metatarsalgia, run by University of Seville at 1 site in Spain.
Trial summary
The therapeutic plan for certain pathologies in the adult population typically includes the performance of moderate physical activity aimed at preventing cardiovascular risk due to sedentary lifestyle, improving muscle tone and balance to prevent falls, enhancing bone health, and maintaining proper functional and… Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metatarsalgia
- What is being tested?
- Socks, Standard device and Foot orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female sex;
- Age ≥ 55 years;
- Experiencing moderate to severe pain in the plantar area of the forefoot;
- Presenting hyperkeratosis under the central metatarsal heads;
- Presenting pre-dislocation syndrome of the second or third metatarsophalangeal joint.
Who cannot join
- Present cognitive deterioration that impedes the proper development of the study;
- Have undergone previous osteoarticular surgeries on the feet;
- Diagnosis of rheumatoid arthritis with involvement in the metatarsophalangeal joints of the foot;
- Present symptoms compatible with Morton's neuritis;
- Use of walking aids;
- Are under treatment with insoles;
- Refuse the use of designated socks or plantar supports during the follow-up period.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Enfermería, Fisioterapia y Podología
Seville, Seville, 41008
About this study
Official title: Identification of Baropodometric Patterns Associated With Metatarsalgia and Custom Design of Its Three-dimensional Element of Discharge to Integrate it in Stockings or Socks
The therapeutic plan for certain pathologies in the adult population typically includes the performance of moderate physical activity aimed at preventing cardiovascular risk due to sedentary lifestyle, improving muscle tone and balance to prevent falls, enhancing bone health, and maintaining proper functional and mental health state. However, this activity can be hindered by pain arising from musculoskeletal injuries of low or moderate significance. One such injury is metatarsalgia, characterized by acute or chronic pain in the plantar area of the forefoot due to an overload of plantar pressure. It affects one or several central metatarsals and their respective metatarsophalangeal joints. Metatarsalgia is a highly prevalent pathology (up to 83%) in patients aged 60 or older and negatively impacts their quality of life. To alleviate plantar pressure in the affected area, metatarsal offloading devices are commonly used, which can now be integrated into socks or stockings. This integration aids in pain reduction through an everyday, easy-to-use item. However, only preliminary results of their effectiveness exist, and are in a standard model without customization for the patient's foot. Therefore, the goal is to identify different plantar pressure patterns in a sample of female patients over 55 years with metatarsalgia and design personalized three-dimensional plantar elements that can be integrated into the sock's structure to reduce over pressure and improve the clinical picture. A prior evaluation of pain (Foot Pain and Disability Index), impact on quality of life (SF-12 questionnaire), assessment of physical activity (IPAQ), and baropodometric evaluation with instrumented Pedar® insoles (Novel, Germany) will be conducted. This will characterize the patterns of plantar pain. Using 3D scanning of the foot, a personalized three-dimensional element for each plantar pain pattern will be designed to relieve this excess load, and will be integrated into the body of the sock through weaving, thermofusion, or thermosealing. This sample of patients with metatarsalgia will be randomly divided into three groups, who for a period of six months will wear the offloading sock model, personalized plantar supports with selective offloading, or a stabilizing element for the affected metatarsal head that the patient can apply and remove themselves. After these six months, plantar pain, quality of life, and physical activity levels will be re-evaluated in the three groups to determine the potential efficacy of the experimental sock compared to the best possible treatment, insoles, and another common element such as alignment devices. The offloading sock would provide a personalized solution for each patient, requiring no adaptation or frequent replacement, thus creating better adherence to treatment. The number of effective treatment usage hours would increase since socks are part of the patients' regular attire. Additionally, associated costs would be reduced, as there would be no need for frequent replacement of removable pads, stabilizing devices, or regular revisions to adjust orthopedic insoles.
- Conditions
- Metatarsalgia
- Being tested
- Socks, Standard device, Foot orthoses
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SocksDevice
Plantar orthotic elements will be designed, according to the participants' previous baropodometric pattern, to alleviate pathological plantar pressure. These elements will be integrated into commonly worn items by patients, such as stockings or socks.
Standard deviceDevice
Removable device of digital alignment to stabilize and unload the affected metatarsophalangeal joint. They do not require frequent replacement as they are washable and reusable elements.
Foot orthosesDevice
Custom-made foot orthoses.
| Study group | Role | What they receive |
|---|---|---|
| Socks | Experimental | The intervention will be the daily use of socks with the integration of the customized orthotic element. Receives: Device: Socks |
| Standard device | Other | The intervention will be the daily use of external orthotic elements (to be put on and taken off daily) and of standard manufacture. Receives: Device: Standard device |
| Foot orthoses | Other | The participants will receive completely personalized plantar supports integrating the relief element. Receives: Device: Foot orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Score 11
Pain under the metatarsal heads of the feet, using the Numeric Pain Rating Score 11 (NPRS-11), in which the minimum value is 0 (no pain) and the maximum value is 10 (the worst imaginable pain).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Oct 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetatarsalgiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro V. Munuera-Martínez, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534073
- Sponsor's protocol ID
- N2009020
- Acronym
- IMEDESCAL
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2024
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned that the datasets generated during the project will be deposited in the institutional repository of the University of Extremadura and the University of Seville, whose metadata are aggregated to RECOLECTA of the Fundación Española para la Ciencia y la Tecnología (FECYT) and OpenAIRE Explore. The repository uses the generic Dublin Core metadata standard for dataset description and provides a handle as a permanent identifier. Data that contains potentially identifiable information about human subjects will not be publicly shared. And they cannot be disclosed until the patents related to this research are managed. In all activities carried out during this project, the fundamental principles of research integrity will be respected, following the Code of Good Research Practices of the University of Extremadura and the University of Seville, and all necessary procedures will be followed to comply with current data protection legislation.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Baropodometric Patterns Associated With Metatarsalgia and Custom Design of Its Three-dimensional Element of Discharge to Integrate it in Stockings or Socks
- ClinicalTrials.gov ID
- NCT06534073
- Acronym / sponsor ID
- IMEDESCAL / N2009020
- Conditions
- Metatarsalgia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Aug 2024 (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.
The therapeutic plan for certain pathologies in the adult population typically includes the performance of moderate physical activity aimed at preventing cardiovascular risk due to sedentary lifestyle, improving muscle tone and balance to prevent falls, enhancing bone health, and maintaining proper functional and mental health state. However, this activity can be hindered by pain arising from musculoskeletal injuries of low or moderate significance. One such injury is metatarsalgia, characterized by acute or chronic pain in the plantar area of the forefoot due to an overload of plantar pressure. It affects one or several central metatarsals and their respective metatarsophalangeal joints. Metatarsalgia is a highly prevalent pathology (up to 83%) in patients aged 60 or older and negatively impacts their quality of life. To alleviate plantar pressure in the affected area, metatarsal offloading devices are commonly used, which can now be integrated into socks or stockings. This integration aids in pain reduction through an everyday, easy-to-use item. However, only preliminary results of their effectiveness exist, and are in a standard model without customization for the patient's foot. Therefore, the goal is to identify different plantar pressure patterns in a sample of female patients over 55 years with metatarsalgia and design personalized three-dimensional plantar elements that can be integrated into the sock's structure to reduce over pressure and improve the clinical picture. A prior evaluation of pain (Foot Pain and Disability Index), impact on quality of life (SF-12 questionnaire), assessment of physical activity (IPAQ), and baropodometric evaluation with instrumented Pedar® insoles (Novel, Germany) will be conducted. This will characterize the patterns of plantar pain. Using 3D scanning of the foot, a personalized three-dimensional element for each plantar pain pattern will be designed to relieve this excess load, and will be integrated into the body of the sock through weaving, thermofusion, or thermosealing. This sample of patients with metatarsalgia will be randomly divided into three groups, who for a period of six months will wear the offloading sock model, personalized plantar supports with selective offloading, or a stabilizing element for the affected metatarsal head that the patient can apply and remove themselves. After these six months, plantar pain, quality of life, and physical activity levels will be re-evaluated in the three groups to determine the potential efficacy of the experimental sock compared to the best possible treatment, insoles, and another common element such as alignment devices. The offloading sock would provide a personalized solution for each patient, requiring no adaptation or frequent replacement, thus creating better adherence to treatment. The number of effective treatment usage hours would increase since socks are part of the patients' regular attire. Additionally, associated costs would be reduced, as there would be no need for frequent replacement of removable pads, stabilizing devices, or regular revisions to adjust orthopedic insoles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Socks | Experimental | Device: SocksThe intervention will be the daily use of socks with the integration of the customized orthotic element. |
| Standard device | Other | Device: Standard deviceThe intervention will be the daily use of external orthotic elements (to be put on and taken off daily) and of standard manufacture. |
| Foot orthoses | Other | Device: Foot orthosesThe participants will receive completely personalized plantar supports integrating the relief element. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female sex;
- Age ≥ 55 years;
- Experiencing moderate to severe pain in the plantar area of the forefoot;
- Presenting hyperkeratosis under the central metatarsal heads;
- Presenting pre-dislocation syndrome of the second or third metatarsophalangeal joint.
Key exclusion criteria (7 listed)
- Present cognitive deterioration that impedes the proper development of the study;
- Have undergone previous osteoarticular surgeries on the feet;
- Diagnosis of rheumatoid arthritis with involvement in the metatarsophalangeal joints of the foot;
- Present symptoms compatible with Morton's neuritis;
- Use of walking aids;
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 |
|---|---|---|
| SocksPlantar orthotic elements will be designed, according to the participants' previous baropodometric pattern, to alleviate pathological plantar pressure. These elements will be integrated into commonly worn items by patients, such as stockings or socks. | Device | Socks |
| Standard deviceRemovable device of digital alignment to stabilize and unload the affected metatarsophalangeal joint. They do not require frequent replacement as they are washable and reusable elements. | Device | Standard device |
| Foot orthosesCustom-made foot orthoses. | Device | Foot orthoses |
Primary outcome
Numeric Pain Rating Score 11
Time frame: 4 weeks
Pain under the metatarsal heads of the feet, using the Numeric Pain Rating Score 11 (NPRS-11), in which the minimum value is 0 (no pain) and the maximum value is 10 (the worst imaginable pain).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. It is planned that the datasets generated during the project will be deposited in the institutional repository of the University of Extremadura and the University of Seville, whose metadata are aggregated to RECOLECTA of the Fundación Española para la Ciencia y la Tecnología (FECYT) and OpenAIRE Explore. The repository uses the generic Dublin Core metadata standard for dataset description and provides a handle as a permanent identifier. Data that contains potentially identifiable information about human subjects will not be publicly shared. And they cannot be disclosed until the patents related to this research are managed. In all activities carried out during this project, the fundamental principles of research integrity will be respected, following the Code of Good Research Practices of the University of Extremadura and the University of Seville, and all necessary procedures will be followed to comply with current data protection legislation.
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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.
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 Socks, Standard device and Foot orthoses in people with Metatarsalgia, run by University of Seville 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 4 May 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?
This study is still under way. Results are not available in the source record yet.
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?
Numeric Pain Rating Score 11 (time frame: 4 weeks). 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 May 2026.