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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04103866
Recruitment Status : Active, not recruiting
First Posted : September 26, 2019
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Schoenhaus, Jodi, DPM

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.

Condition or disease Intervention/treatment Phase
Metatarsalgia Hyperkeratotic Callus Corns Fat Pad Syndrome Device: Juvederm Voluma Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : April 30, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Pressure Offloading Innersole System
Use of Juvederm Voluma in the foot for fat pad restoration
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103866


Locations
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United States, Florida
Foot, Ankle & Leg Vein Center
Boca Raton, Florida, United States, 33431
Sponsors and Collaborators
Schoenhaus, Jodi, DPM
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Responsible Party: Schoenhaus, Jodi, DPM
ClinicalTrials.gov Identifier: NCT04103866    
Other Study ID Numbers: POIS Study 1
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Metatarsalgia
Foot Diseases
Musculoskeletal Diseases
Joint Diseases
Pain
Neurologic Manifestations