NCT04103866

Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Schoenhaus, Jodi, DPM · Individual
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The current use of Juvederm Voluma XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21. In this particular setting, the intended use of the product Juvederm Voluma XC is to show that the filler works to alleviate stress in high pressure areas in the foot during gait, thus decreasing foot pain and allowing individuals to walk more comfortably.

Conditions

• Metatarsalgia
• Hyperkeratotic Callus
• Corns
• Fat Pad Syndrome

Interventions

Type	Name	Description
DEVICE	Juvederm Voluma	Juvederm will be used in various parts of the foot to increase collagen volume and decrease high pressures of stress typically seen as people age. It will serve to promote the following: foot cushioning due to tissue atrophy, increase comfort when walking, decrease gait peak pressures which will decrease stress on bones and soft tissue and heal calluses, skin lesions, etc. It will also decrease the patient need for balancing and offloading by the use of an in-shoe orthotic device that requires a closed shoe system. Many people complain of pain walking barefoot, in high heels and sandals where orthotics are not effective.

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-04-30
• Completion: 2021-01-30
• First posted: 2019-09-26
• Last updated: 2020-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study