N/A
N=20
Radiofrequency Hyperthermia Safety Study
Chronic Pain · Soft Tissue Injuries · Wound Heal · Blood Flow
Bottom Line
View on ClinicalTrials.gov: NCT05399771 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Mean Temperature Change- Skin Evaluation on Leg With Device — 6.21 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laser Doppler (Device); Radiofrequency Heating System (Device); Thermal Imaging (Device); Healthcare Questionnaire & Measurement (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Temperature Change- Skin Evaluation on Leg With Device |
7.647 | — |
| PRIMARY Mean Temperature Change- Skin Evaluation on Leg With Device |
7.647 | — |
| PRIMARY Mean Temperature Change- Skin Evaluation on Leg With Device |
7.647 | — |
| PRIMARY Mean Temperature Change- Skin Evaluation on Leg With Device |
7.647 | — |
| PRIMARY Mean Change in Blood Perfusion Assessment - mL/kg/Min |
430.312 | — |
| PRIMARY Blood Perfusion Assessment - mL/kg/Min |
29.659 | — |
| PRIMARY Blood Perfusion Assessment - mL/kg/Min |
29.659 | — |
| PRIMARY Blood Perfusion Assessment - mL/kg/Min |
29.659 | — |
| PRIMARY Blood Perfusion Assessment - mL/kg/Min |
29.659 | — |
| PRIMARY Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment |
— | — |
| PRIMARY Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment |
— | — |
| PRIMARY Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment |
— | — |
| PRIMARY Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment |
— | — |
| PRIMARY Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment |
— | — |
| PRIMARY Safety: Number of Blister Formations |
— | — |
| PRIMARY Safety: Significant Changes in Redness |
— | — |
| SECONDARY Number of Participants Who Attended the Session |
16 | — |
| SECONDARY Number of Participants Who Attended the Session |
16 | — |
| SECONDARY Number of Participants Who Attended the Session |
16 | — |
| SECONDARY Number of Participants Who Attended the Session |
16 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05399771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.