Actively Recruiting
Clinical Outcomes Related to Treatment of Ankle Injury Using Semiconductor Embedded Therapeutic Socks: A Randomized, Prospective, Double Blinded Clinical Study
Led by University of Colorado, Denver · Updated on 2026-05-01
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
U
University of Colorado Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of semiconductor embedded socks to improve healing after non-surgical ankle sprains, avulsion fractures, or distal fibular fractures. The study focuses on whether these socks can affect recovery outcomes, injury symptoms, and function during rehabilitation compared to typical compression socks. Ankle sprains are common injuries with high rates of recurrence, and this study aims to explore a novel treatment option using fabric that emits infrared waves and negative ions. Participants will be randomly assigned to wear either semiconductor embedded socks or standard compression socks during a 12-week rehabilitation period. The semiconductor socks are designed to increase blood flow and reduce inflammation by releasing infrared waves and negative ions activated by body heat. These socks are non-compressive and aim to help with pain, swelling, and recovery. The study includes a double-blind design to compare effects between the two sock types. Throughout the study, participants will wear the assigned socks and record symptoms and functional measures. Researchers will collect data at regular intervals, including a primary outcome measured by the FAOS score at 6 months, to assess ankle function and recovery. The study also monitors participants up to one year to evaluate longer-term outcomes. The trial is sponsored by the University of Colorado, Denver, and includes adults aged 18 to 69 with ankle injuries suitable for non-surgical treatment.
CONDITIONS
Brief Title
Semiconductor Embedded Socks for Ankle Sprains
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ankle sprain, avulsion fracture, or distal fibular fracture
- Pain present for at least 1 day
- Age between 18 and 69 years
You will not qualify if you...
- Neurological conditions
- Prior surgical treatment of lower limb injury
- Chronic pain conditions
- Auto-immune or auto-inflammatory diseases
- Tobacco use within the last 90 days
- History of metabolic disorders
- Open wound at the area of sock application
- Acute or systemic infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants wear either the semiconductor embedded therapeutic sock or a control compression sock during a 12-week rehabilitation period for ankle injury.
Weekly visits for up to 12 weeks
Duration - Up to 1 year
Participants have outcome measures collected at standard intervals up to 1 year to evaluate the effectiveness of the treatment.
Visits at 6 months and additional follow-up visits
Trial Site Locations
Total: 1 location
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
S
Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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