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Effect of Semiconductor Embedded Therapeutic Gloves for Hand Osteoarthritis

NCT ID: NCT06744855

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-01-01

Brief Summary

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The goal of this study is to evaluate change in symptoms using semiconductor embedded gloves for hand osteoarthritis.

Detailed Description

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The semiconductor embedded fabric emits mid-level and far infrared waves and negative ions to the tissue which can increase circulation of both blood and lymph, plus facilitates the anti-inflammatory nitric oxide cascade by accelerating the binding of Calcium to Calmodulin. Nitric oxide down-regulates interleukin1 beta and inducible nitric oxide synthase in certain cell types, which leads to reduced cyclooxygenase-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 subjective and clinically measured objective outcomes for hand osteoarthritis pain management and hand function with application of semiconductor embedded fabric in the affected area.

Conditions

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Hand Osteoarthritis Osteoarthritis

Keywords

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Semiconductor embedded fabric gloves for Hand Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Semiconductor circulation gloves

The gloves will have semiconductors embedded in the fabric.

Group Type ACTIVE_COMPARATOR

Non-invasive circulation gloves

Intervention Type DEVICE

Non-invasive class I medical device, circulation gloves with semiconductors embedded in the fabric.

Placebo circulation gloves

The gloves will look identical to the active circulation gloves, but will not have semiconductors embedded into the fabric

Group Type PLACEBO_COMPARATOR

Fabric gloves

Intervention Type DEVICE

These gloves will look and feel identical to the active circulation gloves, but will not have semiconductors embedded in the fabric.

Interventions

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Non-invasive circulation gloves

Non-invasive class I medical device, circulation gloves with semiconductors embedded in the fabric.

Intervention Type DEVICE

Fabric gloves

These gloves will look and feel identical to the active circulation gloves, but will not have semiconductors embedded in the fabric.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients diagnosed with erosive hand OA, non-erosive hand OA, or first carpometacarpal joint OA with a Kellgren- Lawrence grade \>1 as determined by radiographic assessments and the American College of Rheumatology (ACR) classification
2. Patients age 40-75
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 had prior surgical treatment of the hands in the last 5 years or injection treatment in the last 6 months
3. Patient has secondary OA including causes such as gout, rheumatoid arthritis, psoriatic arthritis
4. Patient has used topical creams or gels for arthritic pain including nonsteroidal anti-inflammatory drugs, capsaicin, lidocaine, or counterirritants in the last 1 week
5. Patient has a history of carpal tunnel syndrome, cubital tunnel syndrome, or radial tunnel syndrome
6. Patient has a history of peripheral neuropathy
7. Patient has chronic pain conditions unrelated to hand condition
8. Patient has auto-immune or auto-inflammatory diseases
9. Patient has used tobacco within the last 90 days
10. Patient is not within the ages of 40-75
11. Patient has an active infection (local or systemic)
12. Patient is unwilling or unable to sign the corresponding research subject consent form
13. 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.

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Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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INCREDIWEAR HOLDINGS, INC.

INDUSTRY

Sponsor Role collaborator

Altoona Center for Clinical Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Countries

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United States

References

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Marino K, Lee R, Lee P. Effect of Germanium-Embedded Knee Sleeve on Osteoarthritis of the Knee. Orthop J Sports Med. 2019 Oct 25;7(10):2325967119879124. doi: 10.1177/2325967119879124. eCollection 2019 Oct.

Reference Type RESULT
PMID: 31696136 (View on PubMed)

Other Identifiers

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2024-24

Identifier Type: -

Identifier Source: org_study_id