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

NCT04103866 | Unknown DMC FDA Device

• 1 other identifier: POIS Study 1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• AOFAS

  The primary endpoint is 12 weeks post injection. The endpoint will be evaluated by the foot and ankle outcome questionnaire for improvement of pain scale scores and ability to return to activity. An improvement that is statistically relevant will be considered an overall total improvement

  12 weeks

Secondary Outcomes (1)

• Less pressure

  52 weeks

Study Arms (1)

Pressure Offloading Innersole System

EXPERIMENTAL

Use of Juvederm Voluma in the foot for fat pad restoration

Device: Juvederm Voluma

Interventions

Juvederm Voluma 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.

Pressure Offloading Innersole System

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Schoenhaus, Jodi, DPM: lead

Study Sites (1)

Foot, Ankle & Leg Vein Center

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Conditions

Metatarsalgia; Callosities

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: November 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: January 30, 2021
• Last Updated: October 6, 2020

Record last verified: 2020-05

Locations

US (1)