Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves

NCT07422623 | Not Yet Recruiting

• 1 other identifier: 2025-01
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months

Secondary Outcomes (6)

• Change in participant Foot Function Index (FFI)

  3 months

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

  3 months

• Participant-reported changes in pain

  3 months

• Changes in oral medication intake compared to placebo group

  3 months

• Changes in swelling of the foot compared to placebo group

  3 months

Study Arms (2)

Active Device

ACTIVE COMPARATOR

Semiconductor Embedded Ankle Sleeve and Sock

Device: Semiconductor embedded ankle sleeve and sock

Placebo Device

PLACEBO COMPARATOR

Identical device absent of semiconductors

Device: Placebo ankle sleeve and sock

Interventions

Semiconductor embedded ankle sleeve and sock DEVICE

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

Active Device

Placebo ankle sleeve and sock DEVICE

Identical ankle sleeve and sock absent of semiconductors

Placebo Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• INCREDIWEAR HOLDINGS, INC.: lead

Central Study Contacts

Foot and Ankle Center of Iowa

CONTACT

515-639-3775; Contact@footanklecenteriowa.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02