Effect of Semiconductor Embedded Therapeutic Gloves for Hand Osteoarthritis

NCT06744855 | Enrolling By Invitation FDA Device

• 1 other identifier: 2024-24
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hand Osteoarthritis; Osteoarthritis

Keywords

Semiconductor embedded fabric gloves for Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in pain as measured by the Visual Analog Scale (VAS)

  The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The minimum number is zero meaning no pain and maximum number is 10 meaning the most pain the patient has every felt in their entire life. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain.

  Baseline and weekly for 9 months

Secondary Outcomes (4)

• Change in patient hand function as determined by the Australian Canadian Osteoarthritis Hand Index (AUSCAN)

  Baseline, 3 months, 6 months, and 9 months

• Change in patient hand function as determined by the Functional Index for Hand Osteoarthritis (FIHOA)

  Baseline, 3 months, 6 months, and 9 months

• Change in patient grip strength

  Baseline, 3 months, 6 months, and 9 months

• Radiographic changes as determined by hand x-rays.

  Baseline and 9 months

Study Arms (2)

Semiconductor circulation gloves

ACTIVE COMPARATOR

The gloves will have semiconductors embedded in the fabric.

Device: Non-invasive circulation gloves

Placebo circulation gloves

PLACEBO COMPARATOR

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

Device: Fabric gloves

Interventions

Non-invasive circulation gloves DEVICE

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

Semiconductor circulation gloves

Fabric gloves DEVICE

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

Placebo circulation gloves

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients age 40-75
• Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
• Patients who are willing and able to sign corresponding research subject consent form.

You may not qualify if:

• Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
• Patient has had prior surgical treatment of the hands in the last 5 years or injection treatment in the last 6 months
• Patient has secondary OA including causes such as gout, rheumatoid arthritis, psoriatic arthritis
• Patient has used topical creams or gels for arthritic pain including nonsteroidal anti-inflammatory drugs, capsaicin, lidocaine, or counterirritants in the last 1 week
• Patient has a history of carpal tunnel syndrome, cubital tunnel syndrome, or radial tunnel syndrome
• Patient has a history of peripheral neuropathy
• Patient has chronic pain conditions unrelated to hand condition
• Patient has auto-immune or auto-inflammatory diseases
• Patient has used tobacco within the last 90 days
• Patient is not within the ages of 40-75
• Patient has an active infection (local or systemic)
• Patient is unwilling or unable to sign the corresponding research subject consent form
• 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.

Sponsors & Collaborators

• Altoona Center for Clinical Research: lead
• INCREDIWEAR HOLDINGS, INC.: collaborator

Study Sites (1)

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Related Publications (1)

• 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.

  PMID: 31696136 RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Locations

US (1)