Perforating Fat Injections for Plantar Fasciosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Plantar Fascia
- Sponsor
- University of Pittsburgh
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Plantar fascia thickness
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jeffrey A. Gusenoff, MD
MD
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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. )
Outcomes
Primary Outcomes
Plantar fascia thickness
Time Frame: 6 months
Assessed by ultrasound
Secondary Outcomes
- Plantar foot pain(6 months)
- Local and systemic complications resulting from fat graft procedure(6 months)