Status:

COMPLETED

Radiofrequency Hyperthermia Safety Study

Lead Sponsor:

Wake Forest University Health Sciences

Collaborating Sponsors:

thermofield

Conditions:

Chronic Pain

Soft Tissue Injuries

Eligibility:

All Genders

18-99 years

Phase:

NA

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 r...

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....

Eligibility Criteria

Inclusion

  • 18 years or older
  • Healthy
  • 20\<BMI\<40

Exclusion

  • 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

Key Trial Info

Start Date :

June 27 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 23 2023

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05399771

Start Date

June 27 2022

End Date

October 23 2023

Last Update

May 3 2024

Active Locations (1)

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Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157