Trials / Enrolling By Invitation
Enrolling By InvitationNCT06744855
Effect of Semiconductor Embedded Therapeutic Gloves for Hand Osteoarthritis
Effect of Semiconductor Embedded Therapeutic Gloves on the Mitigation of Hand Osteoarthritis: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Altoona Center for Clinical Research · Network
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to evaluate change in symptoms using semiconductor embedded gloves for hand osteoarthritis.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Non-invasive circulation gloves | Non-invasive class I medical device, circulation gloves with semiconductors embedded in the fabric. |
| DEVICE | Fabric gloves | These gloves will look and feel identical to the active circulation gloves, but will not have semiconductors embedded in the fabric. |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2025-12-31
- Completion
- 2026-01-01
- First posted
- 2024-12-20
- Last updated
- 2025-10-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06744855. Inclusion in this directory is not an endorsement.