Ankle SprainNCT07025733
Semiconductor Embedded Socks for Ankle Sprains
A study testing Semiconductor Embedded Sock in people with Ankle Sprain, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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: 1. How does semiconductor embedded sock effect outcomes in patients undergoing rehabilitation from ankle injury? 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Semiconductor Embedded Sock
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle sprain, avulsion fracture, distal fibular fracture
- Pain for at least 1 day
- Patients 18-69 years old
Who cannot join
- Patients with neurological conditions
- Patients with prior surgical treatment of lower limb injury
- Patients with chronic pain conditions
- Patient with auto-immune or auto-inflammatory disease
- Patients with tobacco use in last 90 days
- Patients with history of metabolic disorders
- Patients with open wound at area of application
- Patients with acute or systemic infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Study Coordinator, 3037243185, nicholas.piccaro@cuanschutz.edu
About this study
Official title: Clinical Outcomes Related to Treatment of Ankle Injury Using Semiconductor Embedded Therapeutic Socks: A Randomized, Prospective, Double Blinded Clinical Study
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:
- How does semiconductor embedded sock effect outcomes in patients undergoing rehabilitation from ankle injury?
- How does semiconductor embedded socks effect injury symptoms and function throughout the course of treatment?
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.
Read the detailed description
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:
- Increase blood flow and velocity
- Reduce osteoarthritis pain
- Reduce effusion post total knee arthroplasty
- Improve chondrogenic differentiation in vitro
- Improve muscle recovery
- Increase blood speed by up to 22% at rest
- Improve functional outcomes
The benefits of the Infrared Wave and Negative Ion therapy include:
- Inhibition of Cox-2 and Prostaglandins in the lipopolysaccharide (LPS)-moderated pain pathway
- Up-regulation of heat shock protein
- Mediated Nitric oxide production
- Increased activity of voltage-gated ion channels
- Increased activity of mechanosensitive ion channels
- Polarization of cell surface membranes
- Protecting muscle damage
- Scavenging of Reactive Oxygen Species (ROS)
- Improved thermoregulation
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
- Determine the effect of the semiconductor embedded sock on outcomes in patients undergoing rehabilitation from ankle injury.
- Evaluate the change in ankle injury symptoms and function in patients throughout the course of treatment with the semiconductor embedded sock.
- Conditions
- Ankle Sprain
- Being tested
- Semiconductor Embedded Sock, Control Compression Sock
- Keywords
- ankle sprain, ligamentous sprain, avulsion fracture, distal fibula fracture
- Medical subject headings
- Ankle Injuries, Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiconductor Embedded SockDevice
Semiconductor Embedded sock will be given to this intervention arm
Control Compression SockDevice
Control sock that is just compression sock
| Study group | Role | What they receive |
|---|---|---|
| Semiconductor Embedded Sock | Experimental | Not described Receives: Device: Semiconductor Embedded Sock |
| Control Compression Sock | Placebo comparator | Not described Receives: Device: Control Compression Sock |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start10 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado Health, INCREDIWEAR HOLDINGS, INC.
- Responsible party
- Sponsor
- Investigators
- Nicholas Alfonso, MD, Principal investigator, University of Colorado Department of Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025733
- Sponsor's protocol ID
- 24-1786
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Related to Treatment of Ankle Injury Using Semiconductor Embedded Therapeutic Socks: A Randomized, Prospective, Double Blinded Clinical Study
- ClinicalTrials.gov ID
- NCT07025733
- Acronym / sponsor ID
- 24-1786
- Conditions
- Ankle Sprain
- Keywords
- ankle sprain, ligamentous sprain, avulsion fracture, distal fibula fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Colorado Health, INCREDIWEAR HOLDINGS, INC.
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How does semiconductor embedded sock effect outcomes in patients undergoing rehabilitation from ankle injury?
- How does semiconductor embedded socks effect injury symptoms and function throughout the course of treatment?
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.
Detailed description
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:
- Increase blood flow and velocity
- Reduce osteoarthritis pain
- Reduce effusion post total knee arthroplasty
- Improve chondrogenic differentiation in vitro
- Improve muscle recovery
- Increase blood speed by up to 22% at rest
- Improve functional outcomes
The benefits of the Infrared Wave and Negative Ion therapy include:
- Inhibition of Cox-2 and Prostaglandins in the lipopolysaccharide (LPS)-moderated pain pathway
- Up-regulation of heat shock protein
- Mediated Nitric oxide production
- Increased activity of voltage-gated ion channels
- Increased activity of mechanosensitive ion channels
- Polarization of cell surface membranes
- Protecting muscle damage
- Scavenging of Reactive Oxygen Species (ROS)
- Improved thermoregulation
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
- Determine the effect of the semiconductor embedded sock on outcomes in patients undergoing rehabilitation from ankle injury.
- Evaluate the change in ankle injury symptoms and function in patients throughout the course of treatment with the semiconductor embedded sock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semiconductor Embedded Sock | Experimental | Device: Semiconductor Embedded Sock |
| Control Compression Sock | Placebo comparator | Device: Control Compression Sock |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ankle sprain, avulsion fracture, distal fibular fracture
- Pain for at least 1 day
- Patients 18-69 years old
Key exclusion criteria (8 listed)
- Patients with neurological conditions
- Patients with prior surgical treatment of lower limb injury
- Patients with chronic pain conditions
- Patient with auto-immune or auto-inflammatory disease
- Patients with tobacco use in last 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semiconductor Embedded SockSemiconductor Embedded sock will be given to this intervention arm | Device | Semiconductor Embedded Sock |
| Control Compression SockControl sock that is just compression sock | Device | Control Compression Sock |
Primary outcome
FAOS Score
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Alfonso, MD principal investigator
University of Colorado Department of Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semiconductor Embedded Sock in people with Ankle Sprain, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (3037243185, fahim.choudhury@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAOS Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.