Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves

Conditions

• Hallux Valgus Deformity

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Mar 1, 2026

Status verified

May 2026

Primary completion

Dec 1, 2026

Completion

Jan 1, 2027

Study Design

Enrollment

115 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Active Device
  Semiconductor Embedded Ankle Sleeve and Sock
• Placebo Comparator: Placebo Device
  Identical device absent of semiconductors

Primary Outcome Measure

Change in participant Foot and Ankle Outcome Score (FAOS) [ Time Frame: 3 months ]

Locations (1)

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