Chronic Pain, Soft Tissue Injuries, Wound Heal, Blood Flow
Conditions
Keywords
mild hyperthermia
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.
Interventions
DEVICELaser 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.
DEVICERadiofrequency 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.
DEVICEThermal Imaging
Study team will take thermal imaging photographs of the treatment area following each treatment.
OTHERHealthcare 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
thermofield
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Perfusion Assessment - mL/kg/Min | 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) |
| Mean Temperature Change- Skin Evaluation on Leg With Device | week 1 | To help determine safety during and after dermal application for generating elevated temperatures |
| Mean Change in Blood Perfusion Assessment - mL/kg/Min | 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) |
| Safety: Significant Changes in Redness | from week 1 through week 8 | Number of participants with significant changes in redness that required intervention. |
| Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | 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. |
| Safety: Number of Blister Formations | From week 1 through week 8 | Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Attended the Session | week 1 | The number of participants who attend hyperthermia sessions will be documented. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Thermofield Temperature Controlled Radiofrequency Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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)
Time frame: week 8
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Blood Perfusion Assessment - mL/kg/Min | 29.659 mL/kg/min | Standard Error 1.68 |
Primary
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)
Time frame: week 2
Population: change in pre and post perfusion for subjects at week 2 - Subject 3 was withdrawn
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Blood Perfusion Assessment - mL/kg/Min | 414.065 mL/kg/min | Standard Error 30.77 |
Primary
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)
Time frame: week 3
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Blood Perfusion Assessment - mL/kg/Min | 470.147 mL/kg/min | Standard Error 37.85 |
Primary
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)
Time frame: week 4
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Blood Perfusion Assessment - mL/kg/Min | 434.967 mL/kg/min | Standard Error 31.96 |
Primary
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.
Time frame: week 1
Population: Subject 3 was withdrawn
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | 0.1 score on a scale | Standard Error 0.1 |
Primary
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.
Time frame: week 3
Population: Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | 0.176 score on a scale | Standard Error 0.09 |
Primary
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.
Time frame: week 4
Population: Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | 0.375 score on a scale | Standard Error 0.2 |
Primary
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.
Time frame: week 8
Population: Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | 0 score on a scale | Standard Error 0 |
Primary
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.
Time frame: week 2
Population: Subject 3 was withdrawn
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | 0.21 score on a scale | Standard Error 0.14 |
Primary
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)
Time frame: week 1
Population: change in pre and post perfusion for subjects at week 1 - Subject 3 was withdrawn
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Mean Change in Blood Perfusion Assessment - mL/kg/Min | 430.312 mL/kg/min | Standard Error 26.71 |
Primary
Mean Temperature Change- Skin Evaluation on Leg With Device
To help determine safety during and after dermal application for generating elevated temperatures
Time frame: week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Mean Temperature Change- Skin Evaluation on Leg With Device | 6.21 degrees | Standard Error 0.478 |
Primary
Mean Temperature Change- Skin Evaluation on Leg With Device
To help determine safety during and after dermal application for generating elevated temperatures
Time frame: week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Mean Temperature Change- Skin Evaluation on Leg With Device | 6.56 Degrees | Standard Error 0.63 |
Primary
Mean Temperature Change- Skin Evaluation on Leg With Device
To help determine safety during and after dermal application for generating elevated temperatures
Time frame: week 3
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Mean Temperature Change- Skin Evaluation on Leg With Device | 7.2 degrees | Standard Error 0.67 |
Primary
Mean Temperature Change- Skin Evaluation on Leg With Device
To help determine safety during and after dermal application for generating elevated temperatures
Time frame: week 4
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Mean Temperature Change- Skin Evaluation on Leg With Device | 7.647 degrees | Standard Error 0.62 |
Primary
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.
Time frame: From week 1 through week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Safety: Number of Blister Formations | 0 blisters observed |
Primary
Safety: Significant Changes in Redness
Number of participants with significant changes in redness that required intervention.
Time frame: from week 1 through week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Safety: Significant Changes in Redness | 0 Participants |
Secondary
Number of Participants Who Attended the Session
The number of participants who attend hyperthermia sessions will be documented.
Time frame: week 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Number of Participants Who Attended the Session | 20 Participants |
Secondary
Number of Participants Who Attended the Session
The number of participants who attend hyperthermia sessions will be documented.
Time frame: week 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Number of Participants Who Attended the Session | 20 Participants |
Secondary
Number of Participants Who Attended the Session
The number of participants who attend hyperthermia sessions will be documented.
Time frame: week 3
Population: Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Number of Participants Who Attended the Session | 17 Participants |
Secondary
Number of Participants Who Attended the Session
The number of participants who attend hyperthermia sessions will be documented.
Time frame: week 4
Population: Subject 8 did not complete this visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thermofield Temperature Controlled Radiofrequency Device | Number of Participants Who Attended the Session | 16 Participants |