Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot (NCT04103866) | Clinical Trial Compass
UnknownNot Applicable
Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
United States29 participantsStarted 2019-11-01
Plain-language 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.