Perforating Fat Injections for Plantar Fasciosis

Completed · Not applicable

Conditions studied: Plantar Fascia

In brief

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.

Key facts

Study ID

NCT02855983

Run by

University of Pittsburgh

People needed

16

Starts

2016-08-01

Expected to finish

2019-12-01

Last updated by the study team

2020-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients meeting the following criteria will be eligible to participate in the study:
• Aged 18 years or older and able to provide informed consent
• Subjects with a diagnosis of Plantar Fasciitis having heel pain that has not improved with splints, exercises or rountine standard of care treatment
• Subjects must have a current relationship with their foot specialist managing the Plantar Fasciitis diagnosis.
• Subjects must be 6 months post any surgical intervention to the affected foot
• Subjects with a history of foot ulcer(s), the ulcer(s) must be healed with no recurrance for six months prior to consent to participate in this study.
• Willing and able to comply with follow up examinations, including ultrasounds and radiographs
• Subjects must be determined by the PI or a Co-Investigator to currently suffer from a diagnosis of chronic plantar fasciitis based on physician examination and foot evaluation.

You may not qualify if…

• 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

Where it is running

• UPMC Plastic Surgery Aesthetic Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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