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Hyperthermia

Radiofrequency Hyperthermia for Skin Treatment

N/A

Recruiting

Led By Nicole Levi, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8

Awards & highlights

Study Summary

This trial will test a new radiofrequency device on 20 people to see if it safely improves skin texture. The device will be applied to one leg while the other serves as a control. There will be 4 treatments over 4 weeks, and follow-up 4 weeks after the last treatment.

Who is the study for?

This trial is for healthy adults over 18 with a BMI between 20 and 40, who have no skin infections, tattoos, metal in the leg, blood clot history, autoimmune disorders or lower limb edema. Pregnant or nursing individuals and those with open wounds on the lower leg are excluded.Check my eligibility

What is being tested?

The study tests a radiofrequency heating system applied to one of the participant's legs compared to the other leg without treatment. It involves weekly sessions for four weeks and checks for tissue changes four weeks after completion using laser Doppler, thermal imaging, and health questionnaires.See study design

What are the potential side effects?

Potential side effects may include localized warmth or heat sensations during treatment. Long-term effects could involve changes in skin temperature regulation or circulation but will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comfort level scores of participants receiving hyperthermia treatment

Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment

Safety during and after dermal application for generating elevated temperatures - skin evaluations

Secondary outcome measures

The number of times that participants attend hyperthermia sessions

Trial Design

1Treatment groups

Experimental Treatment

Group I: Thermofield temperature controlled radiofrequency deviceExperimental Treatment4 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thermal Imaging

2016

Completed Phase 1

~150

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,240 Previous Clinical Trials

1,004,187 Total Patients Enrolled

13 Trials studying Chronic Pain

738 Patients Enrolled for Chronic Pain

ThermofieldUNKNOWN

Nicole Levi, PhDPrincipal InvestigatorAtrium Health Wake Forest Baptist

Media Library

Radiofrequency Hyperthermia (Hyperthermia) Clinical Trial Eligibility Overview. Trial Name: NCT05399771 — N/A

Chronic Pain Research Study Groups: Thermofield temperature controlled radiofrequency device

Chronic Pain Clinical Trial 2023: Radiofrequency Hyperthermia Highlights & Side Effects. Trial Name: NCT05399771 — N/A

Radiofrequency Hyperthermia (Hyperthermia) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05399771 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial accepting applicants over the age of sixty?

"This clinical trial only accepts applicants between 18 and 99 years old. For minors, there are 71 studies available while seniors can choose from 475 trials."

Answered by AI

How many participants are involved in the current clinical investigation?

"Correct. According to information posted on clinicaltrials.gov, the trial has been open for recruitment since June 27th 2022 and was last refreshed two days later. Currently, it is looking to recruit 20 individuals from a single medical centre."

Answered by AI

Are there vacancies in this clinical investigation for participants?

"Affirmative. The clinicaltrials.gov website asserts that this trial, which was initially published on June 27th 2022, is currently seeking candidates to participate in the study. There needs to be a total of 20 individuals recruited from one medical site."

Answered by AI

Am I able to participate in this experiment?

"This trial seeks 20 individuals with wound healing experience, aged between 18 and 99. Key criteria for entry include being over the age of consent, in good health, and having a Body Mass Index that is greater than 20 but less than 40."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiofrequency Hyperthermia Safety Study

2022. "Radiofrequency Hyperthermia Safety Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05399771.

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