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

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ClinicalTrials.gov Identifier: NCT04103866
Recruitment Status : Unknown
Verified May 2020 by Schoenhaus, Jodi, DPM.
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2019
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Schoenhaus, Jodi, DPM

Tracking Information
First Submitted Date  ICMJE September 24, 2019
First Posted Date  ICMJE September 26, 2019
Last Update Posted Date October 6, 2020
Actual Study Start Date  ICMJE November 1, 2019
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metatarsalgia
  • Hyperkeratotic Callus
  • Corns
  • Fat Pad Syndrome
Intervention  ICMJE 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  ICMJE Experimental: Pressure Offloading Innersole System
Use of Juvederm Voluma in the foot for fat pad restoration
Intervention: Device: Juvederm Voluma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 5, 2020)
29
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2019)
30
Estimated Study Completion Date  ICMJE January 30, 2021
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04103866
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Schoenhaus, Jodi, DPM
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Schoenhaus, Jodi, DPM
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Schoenhaus, Jodi, DPM
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP