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NOT YET RECRUITING
NCT07422623
NA

Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves

Sponsor: INCREDIWEAR HOLDINGS, INC.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2026-02-17

Completion Date

2027-01-01

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

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