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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04103866
Other study ID # POIS Study 1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date January 30, 2021

Study information

Verified date May 2020
Source Schoenhaus, Jodi, DPM
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 29
Est. completion date January 30, 2021
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Foot, Ankle & Leg Vein Center Boca Raton Florida

Sponsors (1)

Lead Sponsor Collaborator
Schoenhaus, Jodi, DPM

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 52 weeks
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