An interventional study of Semiconductor Embedded Sock and Control Compression Sock in Ankle Sprain, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to determine if semiconductor fabric embedded in socks can improve healing after non operative ankle sprains. The main questions it aims to answer are:
Researchers will compare semiconductor embedded socks with typical compression socks to determine differences in healing.
Participants will be given the socks and be asked to wear them throughout the healing process and record symptoms and functional measures.
STUDY SUMMARY Injuries to the foot and ankle are highly prevalent, with great susceptibility to various injury types due to high usage and complex structural makeup. Ankle injuries are responsible for over 1 million Emergency Room visits each year, and ankle sprains are seen at an incidence of up to 19.0 - 26.6 per 1000 person-years. Approximately 2 million ankle sprains occur annually in the United States alone, and the incidence of re-injury is high, between 12 - 47% of reported ankle sprains are recurrent following initial injury. Ankle sprains are the most commonly presenting sports-related injury each year. Lateral ankle sprains are the most commonly reported type of ankle sprains compared to syndesmotic and medial sprains, and females are at greater risk of sustaining an ankle sprain compared with male counterparts.
Symptoms include pain, swelling, instability and tenderness. Ankle sprains are generally considered treatable and return to activity and sport are typically expected to be successful with proper rehabilitation adherence and measures taken to reduce risk of complication.
The proposed study seeks to evaluate the effectiveness of a non-compressive, therapeutic socks throughout a 12-week course of rehabilitation for non-surgically treated ankle sprain or fracture injury. Outcome measures will be collected at standard intervals up to 1 year to evaluate effectiveness of treatment.
BACKGROUND Treatment approaches for ankle injuries are dictated by the injury type and severity, and include early immobilization, bracing and splinting, return to mobilization as tolerated, rehabilitation strengthening exercises, stabilizing shoes or devices, and pain medication.
Evidence from Lamb, et. al supports a period of up to 14 days of immobilization in a below-knee cast or Aircast instead of a tubular compression bandage and demonstrates improved quality of ankle function after 3 months.
Unlike compression products, the therapeutic socks which will be used in this study are made with semiconductor embedded fabric. The socks increase blood circulation through activation of the embedded elements with heat of the body, and releases mid and far infrared waves as well as negative ions. Both infrared waves and negative ions are biologically active and mediate inflammatory and pain pathways in the body. The technology has also been shown to:
The benefits of the Infrared Wave and Negative Ion therapy include:
The semiconductor embedded fabric emits mid-level and far infrared waves and negative ions. Delivery of infrared waves and negative ions to the tissue increases circulation of both blood and lymph, facilitates the anti-inflammatory nitric oxide (NO) cascade by accelerating the binding of calcium (Ca2+) to calmodulin (CaM). NO provides several healing factors to the body, increasing blood and lymphatic flow6. Additionally, NO down-regulates interleukin-1 beta (IL1β) and inducible nitric oxide synthase (iNOS) in certain cell types, which leads to reduced cyclooxygenase-2 (COX-2) and prostaglandins - molecules responsible for causing inflammation and pain. Unlike other systemic COX-2 inhibitors such as nonsteroidal anti-inflammatory drugs (NSAIDs), targeted infrared and negative ion therapy stimulate localized reaction pathways, thereby reducing pain and inflammation.
This study seeks to identify subjective and objective outcomes for management of ankle sprain, non-operative distal fracture or avulsion fracture injuries through application of semiconductor embedded socks to the affected area.
OBJECTIVES
Exclusion Criteria:
Device: Semiconductor Embedded Sock
Device: Control Compression Sock
Semiconductor Embedded sock will be given to this intervention arm
Control sock that is just compression sock
FAOS Score
Improved patient function compared to placebo group as determined by pre-treatment and post-treatment Patient Specific Foot Function Index Foot and Ankle Outcome Score (FAOS) compared to placebo group. Range of Scores: \[0-100\], higher scores indicates a better outcome.
Time frame: 6 months
Plan to share: No
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University of Colorado, Denver