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

Primary Purpose

Metatarsalgia, Hyperkeratotic Callus, Corns

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Juvederm Voluma
Sponsored by
Schoenhaus, Jodi, DPM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metatarsalgia

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Foot, Ankle & Leg Vein Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pressure Offloading Innersole System

Arm Description

Use of Juvederm Voluma in the foot for fat pad restoration

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Less pressure
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

Full Information

First Posted
September 24, 2019
Last Updated
October 5, 2020
Sponsor
Schoenhaus, Jodi, DPM
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1. Study Identification

Unique Protocol Identification Number
NCT04103866
Brief Title
Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
Acronym
POIS
Official Title
Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
January 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schoenhaus, Jodi, DPM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metatarsalgia, Hyperkeratotic Callus, Corns, Fat Pad Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pressure Offloading Innersole System
Arm Type
Experimental
Arm Description
Use of Juvederm Voluma in the foot for fat pad restoration
Intervention Type
Device
Intervention Name(s)
Juvederm Voluma
Intervention Description
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 Measure Information:
Title
AOFAS
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Less pressure
Description
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
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Foot, Ankle & Leg Vein Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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