Radiofrequency Hyperthermia Safety Study

Summary

This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. Subjects will receive weekly treatments for 4 weeks, and will be re-evaluated 4 weeks after the last treatment to assess any tissue changes that continue after the treatments have concluded.

Conditions

• Chronic Pain
• Soft Tissue Injuries
• Wound Heal
• Blood Flow

Interventions

DEVICE

Laser Doppler

Study team will use a PeriScan PIM 3 System Laser Doppler to scan for blood perfusion before and after the Thermofield treatment. The PeriScan PIM 3 System is for non-invasive two-dimensional imaging of peripheral tissue.

DEVICE

Radiofrequency Heating System

The radiofrequency will be set to achieve 42°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 42°C, and the treatment time with consistent temperature application will be 30 minutes.

DEVICE

Thermal Imaging

Study team will take thermal imaging photographs of the treatment area following each treatment.

OTHER

Healthcare Questionnaire & Measurement

A survey tool created to collect info from participants including: 1. Name 2. Age 3. Weight/ height 4. Pregnant or nursing? 5. History of blood clots? 6. Any wound healing problems? 7. Any active open wounds on the legs? 8. Any autoimmune disorders? 9. Phone number 10. Email address A measurement of the participants calf will be taken as well using a measuring tape.

Sponsors & Collaborators

• thermofield

  collaborator INDUSTRY

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Nicole Levi, PhD · Atrium Health Wake Forest Baptist

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-27

Primary Completion

2023-10-23

Completion

2023-10-23

FDA Device

Yes

Countries

• United States

Study Locations