Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot (POIS)
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ClinicalTrials.gov Identifier: NCT04103866 |
Recruitment Status :
Active, not recruiting
First Posted : September 26, 2019
Last Update Posted : October 6, 2020
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Condition or disease | Intervention/treatment | Phase |
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Metatarsalgia Hyperkeratotic Callus Corns Fat Pad Syndrome | Device: Juvederm Voluma | Not Applicable |
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 |
Arm | Intervention/treatment |
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Experimental: Pressure Offloading Innersole System
Use of Juvederm Voluma in the foot for fat pad restoration
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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. |
- 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
- 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 |
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
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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.

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
United States, Florida | |
Foot, Ankle & Leg Vein Center | |
Boca Raton, Florida, United States, 33431 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Metatarsalgia Foot Diseases Musculoskeletal Diseases |
Joint Diseases Pain Neurologic Manifestations |