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

NCT ID: NCT04103866

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-01-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pressure Offloading Innersole System

Use of Juvederm Voluma in the foot for fat pad restoration

Group Type: EXPERIMENTAL

Juvederm Voluma

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient's 40 to 75 years of age
• Foot and ankle disability index of at least 55 (based on the majority of people having moderate difficulty in weight-bearing living) and heavy clinical significance of fat atrophy as evaluated by the principal investigator creating a standard analysis.
• Atrophy of the heel or the ball of the foot will be evaluated in the step wise approach.
• Second a clinical exam by the primary investigator

Exclusion Criteria

• Patients who do not have high pressure fat pad atrophy
• Patient is being treated for cancer
• Skin infections
• Unhealed or acute foot fractures
• Patients with a decrease in dorsalis pedis or posterior tibial pulses
• Pregnant or breast-feeding
• Patients who have had previous injections with fillers
• Patients with nerve injury or nerve damage to the foot causing symptoms of numbness, tingling, burning, and sharp shooting or stabbing sensations. This criteria shall be determined by a. direct patient feedback. If the patient verbally states that they have numbness tingling burning sharp shooting or stabbing pains in their feet or ankles they will not be included.

b. Semmes Weinstein Monofilament Testing - Semmes Weinstein monofilament testing will be performed on all patients. The Semmes Weinstein will be performed on the great toe submetatarsal one submetatarsal three submetatarsal five the heel and the dorsum of the foot. If a patient cannot feel the sends Weinstein filament in any of those locations they will be eliminated.

• Active an acute diabetic foot ulceration
• Patients with severe allergies manifested by history of anaphylaxis
• Patients with a history or presence of multiple severe allergies
• Patients with a history of allergies to gram-positive bacterial proteins
• Patients with a history of allergies to lidocaine.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Schoenhaus, Jodi, DPM

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Foot, Ankle & Leg Vein Center

Boca Raton, Florida, United States

Countries

United States

Other Identifiers

POIS Study 1

Identifier Type: -

Identifier Source: org_study_id