N/A Completed N=20 Supportive Care

Radiofrequency Hyperthermia Safety Study

Postoperative Pain · Soft Tissue Injuries · Wound Heal · Blood Flow

Source: ClinicalTrials.gov NCT05399771 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcomePrimary: Mean Temperature Change- Skin Evaluation on Leg With Device — 6.21 degrees

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.

Outcome Measures

Outcome	Result	p-value
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 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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.