The Comparison and Combination of Semiconductor Embedded Therapeutic Arm Sleeves and Platelet-Rich Plasma With Adipose Stem Cell (PRP+ASC) Injections for the Treatment of ECRB Tendinopathy (Lateral Epicondylitis): A Randomized, Double-Blinded, Placebo-Controlled Prospective Clinical Trial
Phase: NA
Conditions: ECRB Tendinopathy
Sponsor: INCREDIWEAR HOLDINGS, INC.

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RESEARCH PROTOCOL 
 
Title: 
The Comparison and Combination of Semiconductor Embedded 
Therapeutic Arm Sleeves and Platelet-Rich Plasma with Adipose 
Stem Cell (PRP+ASC) Injections for the Treatment of ECRB 
Tendinopathy (Lateral Epicondylitis): A Randomized, Double-
Blinded, Placebo-Controlled Prospective Clinical Trial 
Protocol Date: 
28, August 2024 
Sponsor: 
Incrediwear Holdings, Inc. 
 
3120 Thorntree Dr. 
 
Chico, CA 95973 
 
United States 
Investigator: 
Dr. Matt Bayes, MD  
 
17300 North Outer 40 Road, Suite 201, Chesterfield, MO 63005 
 
United States 
 
Study-Related 
Phone Number(s): 
636-778-2900 
 
 
 

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1. STUDY SUMMARY 
Extensor Carpi Radialis Brevis (ECRB) tendinopathy, also known as lateral epicondylitis or 
tennis elbow, is the most prevalent elbow soft tissue injury and affects 1-3% of the population1. 
Repetitive overloading of the tendon and ligaments in the elbow lead to microtraumas, causing 
abnormal angiofibroblastic remodeling and increased pain2. Microtearing occurs most commonly 
at the origin of the extensor carpi radialis brevis (ECRB) tendon. The main symptoms include a 
loss of grip strength, a burning sensation near the ECRB origin site, and pain during daily 
activities such as grasping objects or shaking hands3. Both conditions present a significant injury 
and treatment burden on the population and effective treatment and pain management approaches 
with minimal side effects are needed. 
Novel nonsurgical treatment approaches for ECRB tendinopathy include platelet-rich plasma 
(PRP) injections and stem cell therapy. Ultrasound-guided PRP and adipose-derived stem cells 
(ASCs) injections have shown to be an effective treatment option for patients with chronic 
ECRB tendinopathy4,5,6,7.  
The proposed study seeks to assess the effect of non-compressive semiconductor embedded arm 
sleeves in combination with PRP + ASC injections, throughout a 6-month rehabilitation course for 
patients with ECRB tendinopathy. Outcome measures will be collected at standardized intervals 
to evaluate and compare treatment groups.  
2. BACKGROUND 
Unlike compression products, the semiconductor embedded fabric increases blood circulation 
through activation of the embedded elements with heat of the body8 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 body9. The technology has also been 
shown to:  
• Increase blood flow and velocity10 
• Reduce osteoarthritis pain8 
• Reduce effusion post total knee arthroplasty11 
• Improve chondrogenic differentiation in vitro12 
• Improve muscle recovery13 
• Increase circulation by up to 22% at rest10 
• Improve functional outcomes8, 11 
The benefits of the Infrared Wave and Negative Ion therapy include:  
• Inhibition of Cox-2 and Prostaglandins in the lipopolysaccharide (LPS)-moderated pain 
pathway14 
• Up-regulation of heat shock protein14 
• Mediated Nitric oxide production15 
• Increased activity of voltage-gated ion channels14 
• Increased activity of mechanosensitive ion channels14 

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• Polarization of cell surface membranes14 
• Protecting muscle damage16 
• Scavenging of Reactive Oxygen Species (ROS) 
• Improved thermoregulation17 
 
To date, studies have shown that the semiconductor embedded fabric increase circulation by up 
to 22% at rest, and have shown powerful results in reducing inflammation, swelling, improving 
range of motion in the knee post-surgery, and providing pain relief to the joints. 
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)15.  NO provides several healing factors to the body, increasing 
blood and lymphatic flow15. 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 patient reported and clinically measured outcomes for pain 
management and elbow function with application of semiconductor embedded fabric combined 
with PRP+ASC injections in the affected area. 
3. OBJECTIVES 
 
1. Determine the effect of the semiconductor embedded arm sleeves on patient reported and 
clinically measured outcomes in patients with ECRB tendinopathy.  
2. Evaluate the change in symptoms in patients following treatment with the semiconductor 
embedded arm sleeves. 
 
4. HYPOTHESIS 
Subjects who are assigned and compliant to wearing the semiconductor embedded arm sleeve will 
experience improved outcomes in symptoms, pain management, and elbow function throughout 
the course of the study compared to the patients assigned to wear and compliant with wearing the 
placebo sleeves. 
Primary Endpoint 
Completion of 8 weeks wearing the semiconductor embedded arm sleeves with at least 80 
subjects.  
Secondary Endpoint 

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Completion of 6 months wearing the semiconductor embedded arm sleeves with at least 80 
subjects. Additional subjects may be required to enroll in the study to achieve a total of 80 
subjects who complete all outcome measures for 6 months. 
Primary Outcome 
Improvement in patient function in patients using the semiconductor embedded sleeve compared 
to placebo as measured by PRTEE. 
Secondary Outcomes 
1. Reduction in pain as determined by Numeric Pain Rating Scale or Visual Analog Scale 
(VAS) compared to placebo group. 
2. Improvement in patient function as determined by Patient Specific elbow PROMIS score 
(Disabilities of the Arm, Shoulder, and Hand (DASH) and Patient-Rated Tennis Elbow 
Evaluation (PRTEE)) and the patient specific functional score compared to control and 
placebo groups. 
3. Reduction in symptom severity upon physical examination and improvement in grip 
strength compared to placebo group. 
 
5. STUDY DESIGN 
The study will be prospective, randomized, and double-blinded with at least 80 subjects that will 
be recruited by the principal investigator (PI). Patients meeting enrollment criteria will undergo an 
informed consent discussion prior to any study activity. 
Subjects meeting enrollment criteria and consenting to participation will undergo a 6- month trial.  
Study groups:  
a. Among participants who opt out of receiving PRP+ASC injections as part of their 
routine medical care: 
i. One group will receive active therapy (semiconductor embedded arm 
sleeve) “Incrediwear only” 
ii. One group will receive placebo therapy (arm sleeve absent of 
semiconductor thread) “Sham Incrediwear” 
b. Among participants who choose to receive PRP+ASC injections as part of their 
routine medical care: 
i. One group will receive active therapy with SOC PRP+ASC injections 
(active semiconductor embedded arm sleeves after they have received 
PRP+ ASC injections as part of their routine care) “Incrediwear with SOC 
PRP+ASC injections” 
ii. One group will receive placebo therapy with SOC PRP+ASC injections 
(arm sleeve absent of semiconductor fabric after they have received 
PRP+ASC injections as part of their routine care) “Sham Incrediwear with 
SOC PRP+ASC injections” 

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Subjects will determine whether they would like to receive Standard of Care (SOC) PRP+ASC 
injections. Then, the subjects will be randomly assigned to the study group in which they will 
receive a real or sham semiconductor embedded sleeve. The subjects will be instructed to wear the 
sleeve for a minimum of 12 hours per day, including overnight, for the entire duration of the study. 
Patients will determine whether to receive PRP+ASC injections independent of their participation 
in this research study. Then, they will be assigned to a study group and will either receive a real or 
sham sleeve. Study groups will be blinded, randomly assigned, and block randomized based on 
the severity of ECRB tendinopathy (lateral epicondylitis). Severity of ECRB tendinopathy will be 
ranked as mild, moderate or severe as follows: 
Mild – tendinopathy with no visible tearing of ECRB tendon. 
Moderate – visible partial tear of ECRB tendon, less than 50%  
Severe – greater than 50% tear, but less than 100% tear of ECRB tendon. 
All subjects participating in the study will also be assigned to the standard physical therapy routine, 
without direct interventions including dry needling, Graston blading, laser therapy or 
iontophoresis. 
Inclusion Criteria 
1. Patients diagnosed with ECRB tendinopathy as determined by radiographic assessment or 
ultrasound imaging. 
2. Patients age 18-65 
3. Patients who are willing and able to adhere to follow-up schedule and protocol 
guidelines. 
4. Patients who are willing and able to sign corresponding research subject consent form. 
Exclusion Criteria 
1. Patient has a history of neurological conditions, including multiple sclerosis or 
Parkinson’s disease 
2. Patient has severe medical condition, including recent myocardial infarction, unstable 
angina, heart failure, severe anemia 
3. Patient has had prior surgical treatment of the elbow in the last 5 years or injection 
treatment(s) in the last 2 years 
4. Patient has complete tear of ECRB tendon or other surgical indication 
5. Patient has chronic pain conditions unrelated to elbow condition 
6. Patient has auto-immune or auto-inflammatory diseases 
7. Patient has used tobacco within the last 90 days 
8. Patient is not within the ages of 18-65 
9. Patient has a history of metabolic disorders 
10. Patient has an active infection (local or systemic) 
11. Patient is unwilling or unable to sign the corresponding research subject consent form 

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12. Patient meets any other criteria or has any other condition that, in the opinion of the 
investigator, would prevent them from completing the study or that, in the opinion of the 
investigator, would confound study results. 
Study Measures 
Subjects will complete a variety of repeated subjective and objective measures throughout the 
course of the study. A schedule of study-related events can be found in Table 1.  
TABLE 1 
Enrollment 
Visit 
2-Week 
Follow-Up 
Phone Call 
4-Week 
Follow-
Up Phone 
Call 
8-Week 
Follow-
Up Visit 
3 Month 
Follow-Up 
Phone Call 
6 Month 
Follow-Up 
Visit 
*Daily 
Reported 
Enrollment 
Screening 
X 
 
 
 
 
 
 
Informed 
Consent 
Discussions 
X 
 
 
 
 
 
 
PROM 
Scores18, 19 
X 
X 
X 
X 
X 
X 
 
Numeric 
Visual Analog 
Scale20 
X 
X 
X 
X 
X 
X 
X 
Patient 
Specific 
Functional 
Score21 
X 
X 
X 
X 
X 
X 
 
PFG 
Measurement 
(Grip Strength 
Test)22 
X 
 
 
X 
 
X 
 
Device Usage 
Log 
 
 
 
 
 
 
X 
Medications 
Log 
 
 
 
 
 
 
X 
*Daily reported measures will only be required up to the 8-week timepoint.  
Description of Measures 
Enrollment Screening: Patient demographic information, past medical history, weight, history of 
pain, prior treatments, and any secondary diagnoses will be recorded to ensure the patient is a 
candidate for the trial. 

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Informed Consent Discussion: Doctor or study staff will explain the research, go through 
corresponding research subject consent form, and answer patient questions. 
(Disabilities of the Arm, Shoulder, and Hand (DASH) and Patient-Rated Tennis Elbow Evaluation 
(PRTEE))18,19: Patient will report the difficulty in performing various activities, elbow-related 
quality of life, and the level of pain experienced in the previous week.  
Visual Analog Scale (VAS)20: Patient will self-report pain level in the shoulder on a 0-10 scale at 
the same time each day for consistency. 
Patient Specific Functional Score21: Patient will identify and score up to three important activities 
they are unable to do or have difficulty doing due to elbow injury. 
Hand Grip Strength Test22: Doctor or study staff will measure the patient’s grip strength with a 
dynamometer. 
Device Usage Log: Patient will self-report device usage, including time of therapy initiation, time 
of therapy completion, and device location. 
Medications Log: Patient will self-report medication intake, including type and quantity. 
Statistical Analysis 
Relevant clinical variables and demographic characteristics will be summarized by standard 
descriptive summaries (e.g. means, standard deviations, minimums, maximums, confidence limits, 
percentiles). 
6. COMPLIANCE STATEMENT 
This study will be conducted in full accordance with all applicable Federal and State laws and 
regulations including 45 CFR 46. All episodes of noncompliance will be documented. The 
investigators will perform the study in accordance with this protocol, will obtain consent, and will 
report unanticipated problems involving risks to subjects or others in accordance with Western 
IRB Policies and Procedures and all federal requirements. Collection, recording, and reporting of 
data will be accurate and will ensure the privacy, health, and welfare of research subjects during 
and after completion of the study. 
7. RISK AND SAFETY MANAGEMENT  
This study utilizes a treatment with no demonstrated side effects. There is minimal risk involved 
with the treatment or evaluation of the subject associated with this study. The primary risk in this 
study is the identification of individuals. However, all project staff with access to study data are 
accustomed to working with PHI-related, identifiable data and have completed requisite human 
subjects and data protection training. Additionally, safeguards are in place that will limit access to 
project folders to only the individuals directly involved with data collection and analysis. Data are 
stored in a secure electronic folder on the PI’s server, and patient identifiers will be securely stored 

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separately from other information in data sets. The data collected for the study will be stored in a 
secure electronic database to which only the investigators will have access. Data analysis will 
occur using de-identified methods. 
 
Monitoring/Reporting of AE/SAE 
 
The adverse events associated with PRP injections include skin reaction and local injection site 
pain. There is minimal risk with the semiconductor sleeves and as such we do not expect any 
adverse events.  The main risk with this type of study is breach of confidentiality through the 
potential identification of individuals included in the study. If a breach of confidentiality occurs, 
the principal investigator and the project team will work together to report it to the compliance 
office and IRB and will follow the appropriate procedures.  However, all standard procedures will 
be followed to ensure data privacy is maintained, i.e., by storing data in a limited access secure 
folder that is on the PI’s server. 
 
Study Oversight 
 
If study data are requested for monitoring, auditing, or regulatory inspection, the principal 
investigator will provide them in a timely manner. The study investigators will address all possible 
concerns and safety issues are not anticipated. There are no reasons why this study would need to 
be prematurely terminated and therefore oversight is not applicable. 
 
Data Management 
 
All study related data will be stored in a limited access folder that is on the PI’s network. Some 
analysis of de-identified data may be conducted by Sponsor consultants, all of whom completed 
requisite human subjects and data protection training. All analysis will be conducted using 
Microsoft Excel or SPSS version 25. 
 
IRB Review/Ethics/Informed Consent 
 
All potential participants will be provided a research subject consent form and time with their 
doctor to go over this form. Only subjects who are willing and able to sign the consent form will 
participate in the study. Subjects may choose to opt out of the study at any time and will be 
informed of this. Data collected for this study will be obtained from the patient electronic medical 
record (EMR), questionnaires completed by the subject, and in case report forms completed by the 
PI or study staff. This study is being conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and 
applicable regulatory requirements. The study is being conducted in accordance with applicable 
regulations, applicable laws and the IRB requirements. The investigators will submit any change 
to the protocol to the IRB for review and approval before implementation. 
 
Confidentiality 
 

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Only members of the PI’s study team will have access to identifying data as part of this study. All 
involved staff at the PI’s institution routinely work with patient data for purposes of clinical care 
and/or research and as such will follow standard procedures for protecting data privacy. All study 
related data will reside in secure, password-protected databases and folders with access limited to 
the people conducting data collection and analysis. All patient identifiers will be securely stored 
separately from other information in data sets and these identifiers will be eliminated from data 
sets after analysis is complete and results are published. All study records identifying the subjects 
will be kept confidential and will not be made publicly available or presented in any publications. 
Any monitor, auditor, IRB and/or other regulatory authorities will have access to the existing 
dataset on which these analyses will be based. The datasets will contain medical record 
information, but will not be directly linked to the record in its entirety. 
 
Intended Use of the Data 
 
Data will be stored and used for the duration of time required to conduct analysis and publish all 
proposed peer-reviewed papers, according to study objectives. Data will be retained for 2 years 
after publication to allow for re-analysis that may be initiated in response to readers/reviewers. 
Subject records will be maintained at the PI’s clinical site for a minimum of 7 years following 
latest study follow-up.  
 
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