Semiconductor Embedded Socks for Ankle Sprains
Clinical Outcomes Related to Treatment of Ankle Injury Using Semiconductor Embedded Therapeutic Socks: A Randomized, Prospective, Double Blinded Clinical Study
1 other identifier
interventional
100
1 country
1
Brief 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.How does semiconductor embedded socks effect injury symptoms and function throughout the course of treatment?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2025
CompletedFirst Submitted
Initial submission to the registry
June 9, 2025
CompletedFirst Posted
Study publicly available on registry
June 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 1, 2026
June 1, 2025
1.7 years
June 9, 2025
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Study Arms (2)
Semiconductor Embedded Sock
EXPERIMENTALControl Compression Sock
PLACEBO COMPARATORInterventions
Semiconductor Embedded sock will be given to this intervention arm
Eligibility Criteria
You may qualify if:
- Ankle sprain, avulsion fracture, distal fibular fracture
- Pain for at least 1 day
- Patients 18-69 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- University of Colorado Healthcollaborator
- INCREDIWEAR HOLDINGS, INC.collaborator
Study Sites (1)
University of Colorado
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas Alfonso, MD
University of Colorado Department of Orthopedics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Statistician
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2025
First Posted
June 17, 2025
Study Start
April 10, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
May 1, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share