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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
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Inclusion criteria
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.
Primary purpose
Allocation
Interventional model
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29 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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