Perforating Fat Injections for Plantar Fasciosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Plantar fascia thickness
研究概览
简要总结
The specific aim of this study is to determine whether perforating fat injections to the plantar fascia is a safe method to improve pain, quality of life, and reduce plantar fascia thickness for patients with chronic plantar fasciitis. We will also correlate the intrinsic fat properties of adipose stem cells (ie. growth factors) to the improvement in pain, quality of life, and plantar fascia thickness over time.
详细描述
Aim 1: Evaluate the safety of perforating fat injection into the plantar fascia in patients with chronic plantar fasciitis to improve pain, quality of life, and thickness of the fascia.
Rationale: Perforating fat injections have been shown to improve multiple scar and fibrotic conditions such as burn scar contracture, breast radiation injury, and Dupuytren's contracture of the hand. (5-7) It is thought that the perforations allow expansion of the tissues, and filling them with fat allows for a regenerative healing process, rather than an inflammatory scar healing process.
Hypothesis
Perforating fat injections into the chronically thickened plantar fascia is a safe method to improve pain, quality of life, and reduce tissue thickness.
Aim 2: Correlate intrinsic fat properties of lipoaspirate to improvement in function and plantar fascia thickness.
Rationale: Adipose tissue contains adipose derived stem cells. Various growth factors released from the stem cells may have a local effect on soft tissues (ie. VEGF). (8) These stem cells are thought to promote regenerative healing, rather than scar formation and may ultimately improve the thickness of the plantar fascia. (9-12) Hypothesis: Intrinsic fat properties of lipoaspirate (adipose stem cell characteristics) are closely correlated to the improvements in quality of life and thickness of the plantar fascia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Patients with the following characteristics will be excluded from participating in the study:
- •Age less than 18 years
- •Inability to provide informed consent
- •Bilateral foot examination presents with open ulcerations, or diagnosis of osteomyelitis, non-healed fracture, neuropathy or tarsal tunnel syndrome.
- •Diabetics with a HgA1C >7
- •Current active and/or clinically significant infection identified anyway in the body, as demonstrated by physical assessment, laboratory findings, subject report and /or medical history.
- •Diagnosed with systemic or metastatic cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
- •Known coagulopathy
- •Systemic disease that would render the fat harvest and injection procedure, along with associated local anesthetic unsafe to the patient.
- •Any isssue that per the physician's determination would render the patient not appropriate to continue participation in the study (compliance, change in physical status, etc. )
- •Diagnosis of Pregnancy or the intent to of the participant to become pregnant during her participation in this study
- •Subjects with a diagnosis of Schizophrenia or Bipolar Disorder (Subjects who are found to be stable on medication and receive psychiatric clearance from a mental health professional could be eligible for study participation per the Physician's discretion).
- •Tobacco use: Last used anytime within 1 year, beginning and inclusive of date of study screening per subject report. Should the subject begin smoking during study participation, physician at time of notification in change in smoking status to determine subject's continued participation.
- •Morbid obesity: BMI>than or equal to 40
结局指标
主要结局
Plantar fascia thickness
时间窗: 6 months
Assessed by ultrasound
次要结局
- Plantar foot pain(6 months)
- Local and systemic complications resulting from fat graft procedure(6 months)
研究者
Jeffrey A. Gusenoff, MD
MD
University of Pittsburgh