Clinical trial NCT05399771: Radiofrequency Hyperthermia Safety Study
Official title: Radiofrequency Hyperthermia Safety Study (RHySS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Soft Tissue Injuries
Wound Heal
Blood Flow
Keywords: mild hyperthermia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: thermofield
First posted: 2022-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria below. 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).

At the first visit, subjects will be asked to fill out a healthcare questionnaire. With each weekly treatment, subjects will be evaluated to assess how their legs feel on a scale of 1-10, with 1 being no discomfort and 10 being intense pain. Their legs will be photographed before and after radiofrequency MH to examine any visible changes to the tissue. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion before the Thermofield treatment. The radiofrequency will be set to achieve 40°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 40°C, and the treatment time with consistent temperature application will be 30 minutes. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion after the Thermofield treatment ends. Study team will take thermal imaging photographs of the treatment area following each treatment.

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. Subjects will be excluded from the study if they develop any kind of intolerance to the MH treatment, like increased pain or unexpected skin changes. If they receive a significant injury or wound that is not due to the study, such that the skin of the lower leg is no longer intact, they will be excluded from the study.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Healthy
* 20\<BMI\<40

Exclusion Criteria:

* 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
* 40\<BMI \<20
* History of blood clots
* History of lower limb edema
* Tattoos and metal hardware in the leg

Primary outcomes:
measure: Mean Temperature Change- Skin Evaluation on Leg With Device
timeFrame: week 1
measure: Mean Temperature Change- Skin Evaluation on Leg With Device
timeFrame: week 2
measure: Mean Temperature Change- Skin Evaluation on Leg With Device
timeFrame: week 3
measure: Mean Temperature Change- Skin Evaluation on Leg With Device
timeFrame: week 4
measure: Mean Change in Blood Perfusion Assessment - mL/kg/Min
timeFrame: week 1
measure: Blood Perfusion Assessment - mL/kg/Min
timeFrame: week 2
measure: Blood Perfusion Assessment - mL/kg/Min
timeFrame: week 3
measure: Blood Perfusion Assessment - mL/kg/Min
timeFrame: week 4
measure: Blood Perfusion Assessment - mL/kg/Min
timeFrame: week 8
measure: Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
timeFrame: week 1
measure: Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
timeFrame: week 2
measure: Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
timeFrame: week 3
measure: Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
timeFrame: week 4
measure: Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
timeFrame: week 8
measure: Safety: Number of Blister Formations
timeFrame: From week 1 through week 8
measure: Safety: Significant Changes in Redness
timeFrame: from week 1 through week 8
Secondary outcomes:
measure: Number of Participants Who Attended the Session
timeFrame: week 1
measure: Number of Participants Who Attended the Session
timeFrame: week 2
measure: Number of Participants Who Attended the Session
timeFrame: week 3
measure: Number of Participants Who Attended the Session
timeFrame: week 4
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: Nicole Levi, PhD
role: PRINCIPAL_INVESTIGATOR
References: