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

• ClinicalTrials.gov Identifier: NCT04103866
• Recruitment Status: Unknown
• First Posted: September 26, 2019
• Last Update Posted: October 6, 2020
• Sponsor: Schoenhaus, Jodi, DPM
• Information provided by (Responsible Party): Schoenhaus, Jodi, DPM

Tracking Information

• First Submitted Date: September 24, 2019
• First Posted Date: September 26, 2019
• Last Update Posted Date: October 6, 2020
• Actual Study Start Date: November 1, 2019
• Actual Primary Completion Date: April 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2020)

AOFAS [ Time Frame: 12 weeks ]

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

Original Primary Outcome Measures (submitted: September 24, 2019)

Return to activity with less pain [ Time Frame: 12 weeks ]

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. Ultrasound and gait analysis will still be performed at the 12 week mark.

Current Secondary Outcome Measures (submitted: May 1, 2020)

Less pressure [ Time Frame: 52 weeks ]

Follow up evaluations: week two, week 24, and week 52. Follow-up evaluation includes: gate pressure mapping with an improvement being a statistically relevant improvement in peek pressure scores before and after treatment

Original Secondary Outcome Measures (submitted: September 24, 2019)

Less pressure and pain with walking [ Time Frame: 52 weeks ]

Follow up evaluations: week two, week 24, and week 52. Follow-up evaluation includes: gate pressure mapping, ultrasound measurements and foot and ankle outcome questionnaire (see separate document).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
• Official Title: Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Metatarsalgia
• Hyperkeratotic Callus
• Corns
• Fat Pad Syndrome

Intervention

Device: Juvederm Voluma

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.

Study Arms

Experimental: Pressure Offloading Innersole System

Use of Juvederm Voluma in the foot for fat pad restoration

Intervention: Device: Juvederm Voluma

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: October 5, 2020): 29
• Original Estimated Enrollment (submitted: September 24, 2019): 30
• Estimated Study Completion Date: January 30, 2021
• Actual Primary Completion Date: April 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04103866
• Other Study ID Numbers: POIS Study 1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Schoenhaus, Jodi, DPM
• Original Responsible Party: Same as current
• Current Study Sponsor: Schoenhaus, Jodi, DPM
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Schoenhaus, Jodi, DPM
• Verification Date: May 2020