Heat Wrap Device Safety With Age and Body Fat

Pfizer

Status: Completed

Conditions: Back Pain

Treatments: Device: ThermaCare heatwrap; Device: thermal therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01355653

TC-09-12

B3571002

Details and patient eligibility

About

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.

Full description

Safety measurements

Enrollment: 45 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

45 participants in 2 patient groups

Treatment A

Experimental group

Description:

thermal therapy

Treatment:

Device: thermal therapy

Treatment B

Active Comparator group

Description:

ThermaCare Lower Back/Hip heatwrap

Treatment:

Device: ThermaCare heatwrap