Trial Outcomes & Findings for Radiofrequency Hyperthermia Safety Study (NCT NCT05399771)
NCT ID: NCT05399771
Last Updated: 2024-05-03
Results Overview
To help determine safety during and after dermal application for generating elevated temperatures
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
week 1
Results posted on
2024-05-03
Participant Flow
Unit of analysis: Legs
Participant milestones
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
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|---|---|
|
Overall Study
STARTED
|
20 40
|
|
Overall Study
Radiofrequency Heating System
|
20 20
|
|
Overall Study
No Heating
|
20 20
|
|
Overall Study
COMPLETED
|
16 32
|
|
Overall Study
NOT COMPLETED
|
4 8
|
Reasons for withdrawal
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
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|---|---|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Radiofrequency Hyperthermia Safety Study
Baseline characteristics by cohort
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=20 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 1To help determine safety during and after dermal application for generating elevated temperatures
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=20 Legs
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Mean Temperature Change- Skin Evaluation on Leg With Device
|
6.21 degrees
Standard Error 0.478
|
PRIMARY outcome
Timeframe: week 2To help determine safety during and after dermal application for generating elevated temperatures
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=20 legs
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Mean Temperature Change- Skin Evaluation on Leg With Device
|
6.56 Degrees
Standard Error 0.63
|
PRIMARY outcome
Timeframe: week 3Population: Subject 3 was withdrawn after treatment 2 because he developed a red spot and ultimately a small wound. Subject 9 and 10 were withdrawn after treatment 2 because they developed a lump under the skin.
To help determine safety during and after dermal application for generating elevated temperatures
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=17 legs
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Mean Temperature Change- Skin Evaluation on Leg With Device
|
7.2 degrees
Standard Error 0.67
|
PRIMARY outcome
Timeframe: week 4Population: Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete - Subject 20 temperature check was not measured
To help determine safety during and after dermal application for generating elevated temperatures
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=15 legs
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Mean Temperature Change- Skin Evaluation on Leg With Device
|
7.647 degrees
Standard Error 0.62
|
PRIMARY outcome
Timeframe: week 1Population: change in pre and post perfusion for subjects at week 1 - Subject 3 was withdrawn
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)
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=19 legs
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Mean Change in Blood Perfusion Assessment - mL/kg/Min
|
430.312 mL/kg/min
Standard Error 26.71
|
PRIMARY outcome
Timeframe: week 2Population: change in pre and post perfusion for subjects at week 2 - Subject 3 was withdrawn
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)
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=19 legs
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Blood Perfusion Assessment - mL/kg/Min
|
414.065 mL/kg/min
Standard Error 30.77
|
PRIMARY outcome
Timeframe: week 3Population: change in pre and post perfusion for subjects at week 3 - Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 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)
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=17 legs
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Blood Perfusion Assessment - mL/kg/Min
|
470.147 mL/kg/min
Standard Error 37.85
|
PRIMARY outcome
Timeframe: week 4Population: change in pre and post perfusion for subjects at week 4 - Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete - Subject 16 perfusion check was not measured
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)
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=15 legs
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
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|---|---|
|
Blood Perfusion Assessment - mL/kg/Min
|
434.967 mL/kg/min
Standard Error 31.96
|
PRIMARY outcome
Timeframe: week 8Population: Perfusion without treatment at week 8 - Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete
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)
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=16 legs
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Blood Perfusion Assessment - mL/kg/Min
|
29.659 mL/kg/min
Standard Error 1.68
|
PRIMARY outcome
Timeframe: week 1Population: Subject 3 was withdrawn
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.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=19 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
|
0.1 score on a scale
Standard Error 0.10
|
PRIMARY outcome
Timeframe: week 2Population: Subject 3 was withdrawn
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.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=19 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
|
0.21 score on a scale
Standard Error 0.14
|
PRIMARY outcome
Timeframe: week 3Population: Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 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.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=17 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
|
0.176 score on a scale
Standard Error 0.09
|
PRIMARY outcome
Timeframe: week 4Population: Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete
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.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=16 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
|
0.375 score on a scale
Standard Error 0.20
|
PRIMARY outcome
Timeframe: week 8Population: Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete
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.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=16 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
|
0 score on a scale
Standard Error 0
|
PRIMARY outcome
Timeframe: From week 1 through week 8Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=20 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
|
|---|---|
|
Safety: Number of Blister Formations
|
0 blisters observed
|
PRIMARY outcome
Timeframe: from week 1 through week 8Number of participants with significant changes in redness that required intervention.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=20 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
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Safety: Significant Changes in Redness
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0 Participants
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SECONDARY outcome
Timeframe: week 1The number of participants who attend hyperthermia sessions will be documented.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=20 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
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Number of Participants Who Attended the Session
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20 Participants
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SECONDARY outcome
Timeframe: week 2The number of participants who attend hyperthermia sessions will be documented.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=20 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
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Number of Participants Who Attended the Session
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20 Participants
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SECONDARY outcome
Timeframe: week 3Population: Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2
The number of participants who attend hyperthermia sessions will be documented.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=17 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
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Number of Participants Who Attended the Session
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17 Participants
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SECONDARY outcome
Timeframe: week 4Population: Subject 8 did not complete this visit
The number of participants who attend hyperthermia sessions will be documented.
Outcome measures
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=17 Participants
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
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Number of Participants Who Attended the Session
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16 Participants
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Adverse Events
Thermofield Temperature Controlled Radiofrequency Device
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Thermofield Temperature Controlled Radiofrequency Device
n=20 participants at risk
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).
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.
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.
Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment.
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Skin and subcutaneous tissue disorders
Burn/knot
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15.0%
3/20 • Number of events 3 • Adverse event data was collected throughout the life of the study (8 weeks).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place