Heat Wrap Device Safety With Age and Body Fat

NCT ID: NCT01355653

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-05

Study Completion Date

2011-07-28

Brief Summary

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This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Detailed Description

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Safety measurements

Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment A

thermal therapy

Group Type EXPERIMENTAL

thermal therapy

Intervention Type DEVICE

heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day

Treatment B

ThermaCare Lower Back/Hip heatwrap

Group Type ACTIVE_COMPARATOR

ThermaCare heatwrap

Intervention Type DEVICE

heatwrap, topical, one time application, 8 hour duration

Interventions

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thermal therapy

heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day

Intervention Type DEVICE

ThermaCare heatwrap

heatwrap, topical, one time application, 8 hour duration

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2
* or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or \< 30 kg/m2
* Females who are not pregnant or breastfeeding
* Subject is medically cleared for study participation

Exclusion Criteria

* No sensitivitiy or allergy to device components in contact with skin
* Diabetes
* Any active skin disease or tattoos at the test site that would affect participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Loma Linda University

Loma Linda, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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TC-09-12

Identifier Type: OTHER

Identifier Source: secondary_id

B3571002

Identifier Type: -

Identifier Source: org_study_id

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