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

Status unconfirmed · Not applicable

Conditions studied: Metatarsalgia, Hyperkeratotic Callus, Corns, Fat Pad Syndrome

In brief

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.

Key facts

Study ID

NCT04103866

Run by

Schoenhaus, Jodi, DPM

People needed

29

Starts

2019-11-01

Expected to finish

2021-01-30

Last updated by the study team

2020-10-06

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Foot, Ankle & Leg Vein Center — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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