Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hallux Valgus Deformity
• Intervention / Treatment: Device: Semiconductor embedded ankle sleeve and sock; Device: Placebo ankle sleeve and sock

• Study Type: Interventional
• Enrollment (Estimated): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Ankeny, Iowa, United States, 50023
      • Foot and Ankle Center of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Device; Identical device absent of semiconductors	Device: Placebo ankle sleeve and sock; Identical ankle sleeve and sock absent of semiconductors
Active Comparator: Active Device; Semiconductor Embedded Ankle Sleeve and Sock	Device: Semiconductor embedded ankle sleeve and sock; The active device contains semiconductors embedded in the ankle sleeve and sock

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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.	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.	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.	3 months

Collaborators and Investigators

• Sponsor: INCREDIWEAR HOLDINGS, INC.
• Collaborators: foot and ankle center, Iowa

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes