Radiofrequency Hyperthermia Safety Study

NCT05399771 | Completed Results DMC FDA Device

• 1 other identifier: IRB00075221
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mild hyperthermia

Outcome Measures

Primary Outcomes (16)

• Mean Temperature Change- Skin Evaluation on Leg With Device

  To help determine safety during and after dermal application for generating elevated temperatures

  week 1

• Mean Temperature Change- Skin Evaluation on Leg With Device

  To help determine safety during and after dermal application for generating elevated temperatures

  week 2

• Mean Temperature Change- Skin Evaluation on Leg With Device

  To help determine safety during and after dermal application for generating elevated temperatures

  week 3

• Mean Temperature Change- Skin Evaluation on Leg With Device

  To help determine safety during and after dermal application for generating elevated temperatures

  week 4

• Mean Change in Blood Perfusion Assessment - mL/kg/Min

  Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g \* min)

  week 1

• Blood Perfusion Assessment - mL/kg/Min

  Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g \* min)

  week 2

• Blood Perfusion Assessment - mL/kg/Min

  Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g \* min)

  week 3

• Blood Perfusion Assessment - mL/kg/Min

  Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g \* min)

  week 4

• Blood Perfusion Assessment - mL/kg/Min

  Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g \* min)

  week 8

• Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

  A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  week 1

• Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

  A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  week 2

• Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

  A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  week 3

• Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

  A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  week 4

• Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

  A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  week 8

• Safety: Number of Blister Formations

  Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table.

  From week 1 through week 8

• Safety: Significant Changes in Redness

  Number of participants with significant changes in redness that required intervention.

  from week 1 through week 8

Secondary Outcomes (4)

• Number of Participants Who Attended the Session

  week 1

• Number of Participants Who Attended the Session

  week 2

• Number of Participants Who Attended the Session

  week 3

• Number of Participants Who Attended the Session

  week 4

Study Arms (1)

Thermofield temperature controlled radiofrequency device

EXPERIMENTAL

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. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating).

Device: Laser Doppler; Device: Radiofrequency Heating System; Device: Thermal Imaging; Other: Healthcare Questionnaire & Measurement

Interventions

Laser Doppler DEVICE

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.

Also known as: PeriScan PIM 3 System Laser Doppler

Thermofield temperature controlled radiofrequency device

Radiofrequency Heating System DEVICE

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.

Also known as: Thermofield

Thermofield temperature controlled radiofrequency device

Thermal Imaging DEVICE

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

Thermofield temperature controlled radiofrequency device

Healthcare Questionnaire & Measurement OTHER

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.

Thermofield temperature controlled radiofrequency device

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Healthy
• \<BMI\<40

You may not qualify if:

• Pregnant, nursing or child bearing potential
• Active infections of the skin in the lower leg
• Open or healing wounds on the lower leg
• Autoimmune disorder
• \<BMI \<20
• History of blood clots
• History of lower limb edema
• Tattoos and metal hardware in the leg

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• thermofield: collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Chronic Pain; Soft Tissue Injuries

Interventions

Laser-Doppler Flowmetry; Weights and Measures

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Rheology; Investigative Techniques

Results Point of Contact

• Title: Nicole Levi
• Organization: Atrium Health Wake Forest Baptist

nlevi@wakehealth.edu

336-716-4171

Study Officials

• Nicole Levi, PhD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 no the other.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 1, 2022
• Study Start: June 27, 2022
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: May 3, 2024
• Results First Posted: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)