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Enrolling by Invitation

NCT Number: NCT07422623

Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves

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.

Enrolling by Invitation

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foot and Ankle Center of Iowa

Ankeny, Iowa, 50023, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Semiconductor embedded ankle sleeve and sock

Device

The active device contains semiconductors embedded in the ankle sleeve and sock

Placebo ankle sleeve and sock

Device

Identical ankle sleeve and sock absent of semiconductors

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in participant Foot Function Index (FFI)

    Time frame: 3 months

    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)

  2. Changes in participant American Orthopedic Foot and Ankle Society-Hallux Valgus Score (AOFAS)

    Time frame: 3 months

    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)

  3. Participant-reported changes in pain

    Time frame: 3 months

    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)

  4. Changes in oral medication intake compared to placebo group

    Time frame: 3 months

    As measured by collecting concomitant medication information at baseline and changes throughout participation in the study.

  5. Changes in swelling of the foot compared to placebo group

    Time frame: 3 months

    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.

  6. Changes in participant soft tissue thickness compared to placebo group

    Time frame: 3 months

    Changes in participant soft tissue thickness as determined by radiographic assessments (x-ray) of the width of the hallux values in cm.

Sponsors and collaborators

Lead sponsor

INCREDIWEAR HOLDINGS, INC.

Industry

Collaborators

  • foot and ankle center, Iowa

Registry information

Official study title

Clinical Outcomes Related to Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves: A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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