Radiofrequency Hyperthermia Safety Study
CompletedNot applicableNCT05399771
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Radiofrequency Hyperthermia Safety Study (RHySS)
- Conditions
- Chronic Pain
- Soft Tissue Injuries
- Wound Heal
- Blood Flow
- Interventions
- Device: Laser Doppler
- Device: Radiofrequency Heating System
- Device: Thermal Imaging
- Other: Healthcare Questionnaire & Measurement
- Sponsor
- Wake Forest University Health Sciences
- Collaborators
- thermofield
- Start date
- 2022-06-27
- Primary completion
- 2023-10-23
- Sex
- All
- Age range
- from 18 Years to 99 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05399771