Status:
UNKNOWN
Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
Lead Sponsor:
Schoenhaus, Jodi, DPM
Conditions:
Metatarsalgia
Hyperkeratotic Callus
Eligibility:
All Genders
40-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04103866
Start Date
November 1 2019
End Date
January 30 2021
Last Update
October 6 2020
Active Locations (1)
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1
Foot, Ankle & Leg Vein Center
Boca Raton, Florida, United States, 33431