Recruiting

Therapeutic Semiconductor Socks for Ankle Injury Recovery

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What is being tested

Semiconductor Embedded Sock

+ Control Compression Sock
Device
Who is being recruted

Ankle Sprain

From 18 to 70 Years
+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: April 2025

See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Study ContactStudy Coordinator
Last updated: June 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: April 10, 2025Actual date on which the first participant was enrolled.

Ankle injuries, such as sprains and fractures, are common and often occur due to the complex structure and frequent use of the foot and ankle. This study is important because it explores a new treatment option using special therapeutic socks to help people recover from non-surgical ankle injuries. These socks are embedded with semiconductors that can help increase blood circulation, reduce inflammation and pain, and enhance the healing process. The goal is to see if these socks can improve rehabilitation outcomes, reduce the recurrence of injuries, and help people return to their normal activities more effectively. Participants in this study will wear the semiconductor embedded therapeutic socks for 12 weeks as part of their rehabilitation process for ankle injuries. The socks work by using the body's heat to release infrared waves and negative ions, which are believed to improve blood flow and reduce inflammation and pain. Researchers will evaluate the effectiveness of the socks by checking how well participants recover and monitoring their symptoms and ankle function over a period of up to a year. The study aims to provide both subjective feedback from participants and objective measures of improvement to determine if these specialized socks offer a beneficial new approach to ankle injury rehabilitation.

Official TitleClinical Outcomes Related to Treatment of Ankle Injury Using Semiconductor Embedded Therapeutic Socks: A Randomized, Prospective, Double Blinded Clinical Study 
Principal SponsorUniversity of Colorado, Denver
Study ContactStudy Coordinator
Last updated: June 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
100 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Ankle Sprain
Criteria
3 inclusion criteria required to participate
Ankle sprain, avulsion fracture, distal fibular fracture
Pain for at least 1 day
Patients 18-69 years old
8 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Group II
Placebo
Study Objectives
Primary Objectives

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
University of ColoradoAurora, United StatesSee the location
Recruiting
One Study Center