Hallux Valgus DeformityNCT07422623
Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves
A study testing Semiconductor embedded ankle sleeve and sock in people with Hallux Valgus Deformity, run by INCREDIWEAR HOLDINGS, INC. at 1 site in United States.
Trial summary
This study is looking to test a non-compressive semiconductor embedded ankle sleeve and sock for post hallux valgus correction surgery rehabilitation. Hallux valgus (HV), commonly known as a bunion, is one of the most prevalent forefoot deformities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hallux Valgus Deformity
- What is being tested?
- Semiconductor embedded ankle sleeve and sock
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 10 Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hallux valgus correction surgery including Lapiplasty Arthrodesis, MTP fusion, and TMT+MTP arthrodesis (double first ray arthrodesis).
- Patients aged 18-75
- Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- Patients who are willing and able to sign corresponding research subject consent form.
Who cannot join
- Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
- Patient has had prior surgical treatment of the foot within the last 5 years
- Patient has external hardware (wires) protruding from the foot post-surgery
- Patient has had prior injections (PRP or Stem Cell) in the foot within the last 1 year
- Patient has rheumatoid arthritis
Show all 13Show fewer
- Patient has chronic pain conditions unrelated to foot condition
- Patient has auto-immune or auto-inflammatory diseases
- Patient has used tobacco within the last 90 days
- Patient has poorly controlled diabetes as determined by A1C levels > 7.0
- Patient has an active infection (local or systemic)
- Patient is unwilling or unable to sign the corresponding research subject consent form
- Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes Related to Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves: A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation
This study is looking to test a non-compressive semiconductor embedded ankle sleeve and sock for post hallux valgus correction surgery rehabilitation. Hallux valgus (HV), commonly known as a bunion, is one of the most prevalent forefoot deformities. It affects approximately 23% of adults aged 18 to 65 and 36% of those over 65. Given the high incidence of HV, various surgical correction methods have been developed, with first tarsometatarsal (TMT) arthrodesis (Lapiplasty Arthrodesis) and first metatarsophalangeal (MTP) arthrodesis demonstrating the highest success rates in restoring function and preventing recurrence. Post-surgical symptoms typically include pain, swelling, and tenderness, but with proper rehabilitation and preventive measures, patients generally return to activity within weeks to months.The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases far infrared waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for rehabilitation post hallux valgus correction surgery.
- Conditions
- Hallux Valgus Deformity
- Being tested
- Semiconductor embedded ankle sleeve and sock, Placebo ankle sleeve and sock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiconductor embedded ankle sleeve and sockDevice
The active device contains semiconductors embedded in the ankle sleeve and sock
Placebo ankle sleeve and sockDevice
Identical ankle sleeve and sock absent of semiconductors
| Study group | Role | What they receive |
|---|---|---|
| Active Device | Active comparator | Semiconductor Embedded Ankle Sleeve and Sock Receives: Device: Semiconductor embedded ankle sleeve and sock |
| Placebo Device | Placebo comparator | Identical device absent of semiconductors Receives: Device: Placebo ankle sleeve and sock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant Foot and Ankle Outcome Score (FAOS)
Changes in participant function and pain as determined by the Foot and Ankle Outcome score (FAOS)
FAOS:
Lowest score: 0 (extreme symptoms/limiations) Highest score: 100 (no symptoms or limitations)
Measured: 3 months
Secondary outcomes (6)
Change in participant Foot Function Index (FFI)
Changes in participant foot function and pain as determined by the Foot Function Index (FFI) as compared to the placebo group,
FFI:
Lowest score: 0 (no pain or disability) Highest Score: 100 (extreme pain and disability)
Measured: 3 months
Changes in participant American Orthopedic Foot and Ankle Society-Hallux Valgus Score (AOFAS)
Changes in participant hallux valgus function and pain as determined by the American Orthopedic Foot and Ankle Society-Hallux Valgus Score (AOFAS) compared to placebo group.
AOFAS-Hallux MTP-IP Score:
Lowest Score: 0 ( severe pain and disability) Highest Score: 100 ( no pain or disability)
Measured: 3 months
Participant-reported changes in pain
Reduction in post hallux vagus correction surgery pain as determined by the Visual Analog Scale (VAS) compared to placebo group.
Visual Analog Scale for Pain (VAS):
Minimum Value: 0 (no pain) Maximum Value: 10 (worst possible pain)
Measured: 3 months
Changes in oral medication intake compared to placebo group
As measured by collecting concomitant medication information at baseline and changes throughout participation in the study.
Measured: 3 months
Changes in swelling of the foot compared to placebo group
Changes in swelling of the anterior foot width, anterior foot circumference, hallux valgus width, hallux valgus circumference, and 4 cm above and below the patella circumference measurements will be taken in cm.
Measured: 3 months
Changes in participant soft tissue thickness compared to placebo group
Changes in participant soft tissue thickness as determined by radiographic assessments (x-ray) of the width of the hallux values in cm.
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 posted20 Feb 2026
- Study start1 Mar 2026
- Primary completion1 Oct 2026
- Study completion10 Oct 2026
Why it stopped: Product Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus DeformityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- INCREDIWEAR HOLDINGS, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- foot and ankle center, Iowa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422623
- Sponsor's protocol ID
- 2025-01
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Related to Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves: A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation
- ClinicalTrials.gov ID
- NCT07422623
- Acronym / sponsor ID
- 2025-01
- Conditions
- Hallux Valgus Deformity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product Issues
- Enrolment
- 10 participants (actual)
- Lead sponsor
- INCREDIWEAR HOLDINGS, INC.Industry (pharma, biotech, devices)
- Collaborators
- foot and ankle center, Iowa
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 10 Oct 2026 (actual)
- First posted
- 20 Feb 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 is looking to test a non-compressive semiconductor embedded ankle sleeve and sock for post hallux valgus correction surgery rehabilitation. Hallux valgus (HV), commonly known as a bunion, is one of the most prevalent forefoot deformities. It affects approximately 23% of adults aged 18 to 65 and 36% of those over 65. Given the high incidence of HV, various surgical correction methods have been developed, with first tarsometatarsal (TMT) arthrodesis (Lapiplasty Arthrodesis) and first metatarsophalangeal (MTP) arthrodesis demonstrating the highest success rates in restoring function and preventing recurrence. Post-surgical symptoms typically include pain, swelling, and tenderness, but with proper rehabilitation and preventive measures, patients generally return to activity within weeks to months.The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases far infrared waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for rehabilitation post hallux valgus correction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Device | Active comparator | Device: Semiconductor embedded ankle sleeve and sockSemiconductor Embedded Ankle Sleeve and Sock |
| Placebo Device | Placebo comparator | Device: Placebo ankle sleeve and sockIdentical device absent of semiconductors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing hallux valgus correction surgery including Lapiplasty Arthrodesis, MTP fusion, and TMT+MTP arthrodesis (double first ray arthrodesis).
- Patients aged 18-75
- Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- Patients who are willing and able to sign corresponding research subject consent form.
Key exclusion criteria (13 listed)
- Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
- Patient has had prior surgical treatment of the foot within the last 5 years
- Patient has external hardware (wires) protruding from the foot post-surgery
- Patient has had prior injections (PRP or Stem Cell) in the foot within the last 1 year
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 |
|---|---|---|
| Semiconductor embedded ankle sleeve and sockThe active device contains semiconductors embedded in the ankle sleeve and sock | Device | Active Device |
| Placebo ankle sleeve and sockIdentical ankle sleeve and sock absent of semiconductors | Device | Placebo Device |
Primary outcome
Change in participant Foot and Ankle Outcome Score (FAOS)
Time frame: 3 months
Changes in participant function and pain as determined by the Foot and Ankle Outcome score (FAOS) FAOS: Lowest score: 0 (extreme symptoms/limiations) Highest score: 100 (no symptoms or limitations)
6 secondary outcomes
Change in participant Foot Function Index (FFI)
Time frame: 3 months
Changes in participant American Orthopedic Foot and Ankle Society-Hallux Valgus Score (AOFAS)
Time frame: 3 months
Participant-reported changes in pain
Time frame: 3 months
Changes in oral medication intake compared to placebo group
Time frame: 3 months
Changes in swelling of the foot compared to placebo group
Time frame: 3 months
Changes in participant soft tissue thickness compared to placebo group
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Product Issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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 Semiconductor embedded ankle sleeve and sock in people with Hallux Valgus Deformity, run by INCREDIWEAR HOLDINGS, INC. at 1 site in United States.
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 13 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: stopped early, as of the sponsor's last update on 2 Nov 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 United States. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Product Issues). Results are not available in the source record.
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?
Change in participant Foot and Ankle Outcome Score (FAOS) (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 2 Nov 2026.