NCT04103866Unknown不适用
Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
Schoenhaus, Jodi, DPM2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- AOFAS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
AOFAS
时间窗: 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
次要结局
- Less pressure(52 weeks)
研究者
研究点 (2)
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