NCT07422623

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: INCREDIWEAR HOLDINGS, INC. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Semiconductor embedded ankle sleeve and sock	The active device contains semiconductors embedded in the ankle sleeve and sock
DEVICE	Placebo ankle sleeve and sock	Identical ankle sleeve and sock absent of semiconductors

Timeline

• Start date: 2026-02-17
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2026-02-20
• Last updated: 2026-02-20