Semiconductor Embedded Socks for Ankle Sprains

ConditionAnkle Sprain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorUniversity of Colorado, Denver

About this trial

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?

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ankle sprain, avulsion fracture, distal fibular fracture

Pain for at least 1 day

Patients 18-69 years old

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Semiconductor Embedded Sock
Device
Semiconductor Embedded sock will be given to this intervention arm
Control Compression Sock
Device
Control sock that is just compression sock

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Semiconductor Embedded SockExperimental treatment 1 intervention

Group B: Control Compression SockPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

University of Colorado Health

Collaborator

INCREDIWEAR HOLDINGS, INC.

Collaborator

Source ClinicalTrials.gov

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