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

Schoenhaus, Jodi, DPM

Status

Unknown

Conditions

Fat Pad Syndrome

Corns

Metatarsalgia

Hyperkeratotic Callus

Treatments

Device: Juvederm Voluma

Study type

Interventional

Identifiers

NCT04103866

POIS Study 1

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.