Effect of Semiconductor Embedded Therapeutic Gloves for Hand Osteoarthritis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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. -

Exclusion Criteria:

-

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06744855
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Altoona Center for Clinical Research
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hand Osteoarthritis, Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Semiconductor circulation gloves

The gloves will have semiconductors embedded in the fabric.

Placebo Comparator: Placebo circulation gloves

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Altoona Center for Clinical Research, Duncansville, Pennsylvania

Status

Address

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

Site Contact

Lisa A Claycomb, Clinical Research Administrator, CRCP

[email protected]

18009247790