NCT05399771

Radiofrequency Hyperthermia Safety Study

Completed NA Results posted Last updated 3 May 2024

What this trial tests

NA trial testing Laser Doppler in Chronic Pain in 20 participants. Completed in 23 October 2023.

Timeline

27 June 2022

Primary endpoint
23 October 2023

23 October 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	20
Start date	27 June 2022
Primary completion	23 October 2023
Estimated completion	23 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Laser Doppler
• Radiofrequency Heating System
• Thermal Imaging
• Healthcare Questionnaire & Measurement

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Soft Tissue Injuries — all drugs for Soft Tissue Injuries →
• Wound Heal — all drugs for Wound Heal →
• Blood Flow — all drugs for Blood Flow →

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 99, any sex, with Chronic Pain or Soft Tissue Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Temperature Change- Skin Evaluation on Leg With Device Primary · week 1

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

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	6.21	± 0.478

Mean Temperature Change- Skin Evaluation on Leg With Device Primary · week 2

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

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	6.56	± 0.63

Mean Temperature Change- Skin Evaluation on Leg With Device Primary · week 3

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

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	7.2	± 0.67

Mean Temperature Change- Skin Evaluation on Leg With Device Primary · week 4

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

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	7.647	± 0.62

Mean Change in Blood Perfusion Assessment - mL/kg/Min Primary · week 1

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)

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	430.312	± 26.71

Blood Perfusion Assessment - mL/kg/Min Primary · week 2

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)

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	414.065	± 30.77

Blood Perfusion Assessment - mL/kg/Min Primary · week 3

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)

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	470.147	± 37.85

Blood Perfusion Assessment - mL/kg/Min Primary · week 4

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)

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	434.967	± 31.96

Blood Perfusion Assessment - mL/kg/Min Primary · week 8

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)

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	29.659	± 1.68

Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment Primary · week 1

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.

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	0.1	± 0.10

Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment Primary · week 2

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.

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	0.21	± 0.14

Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment Primary · week 3

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.

Group	Value	95% CI
Thermofield Temperature Controlled Radiofrequency Device	0.176	± 0.09

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected throughout the life of the study (8 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Thermofield Temperature Controlled Radiofrequency Device

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	Thermofield Temperature Co…
Burn/knot	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT05399771 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.