Perforating Fat Injections for Plantar Fasciosis

NCT02855983 | Completed DMC

• 1 other identifier: UPittsburgh_PRF
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fascia

Outcome Measures

Primary Outcomes (1)

• Plantar fascia thickness

  Assessed by ultrasound

  6 months

Secondary Outcomes (2)

• Local and systemic complications resulting from fat graft procedure

  6 months

• Plantar foot pain

  6 months

Study Arms (2)

A (Fat grafting initially)

EXPERIMENTAL

A PATHWAY - Intervention: autologous fat grafting to the foot, occur first Fat graft study intervention procedure to occur first, next post-operative follow up visits (V1-V4). The Subject will after Month 6 (V4) crossover to Pathway B to complete Observation visits V1 (Month 2) and V2 (Month 6). After completion of V2 (Month 6), the subject will have completed study participation.

Procedure: Fat Grafting

B (Standard of care initially)

OTHER

B PATHWAY - Intervention: standard of care (observation) for the first year, followed by autologous fat grafting to the foot Observation visit will occur first, next the subject will have two Observation visits V1 (Month 2) and V2 (Month 6). The subject will then crossover to Pathway A. The subject will be assessed by the PI his/her for continued study eligibility. Once the continued eligibility has been determined, the subject will have the interventional fat graft procedure and subsequent post-operative follow up visits (V1-V4). After completion of Post-op V4 (Month 6), the subject will have completed study participation.

Procedure: Fat Grafting

Interventions

Fat Grafting PROCEDURE

Grafting of autologous fat tissue is a minimally invasive surgical technique that starts with the harvest of fat tissue from the abdomen or thighs using liposuction through incisions less than 2mm in length. The lipoaspirate is then processed to concentrate the adipose fraction and reinjected into the graft site. This surgical procedure involves the immediate transplantation of a patient's own tissue in a single operative procedure.

A (Fat grafting initially); B (Standard of care initially)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Plastic Surgery Aesthetic Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Gusenoff BR, Minteer D, Gusenoff JA. Perforating Fat Injections for Chronic Plantar Fasciitis: A Randomized, Crossover Clinical Trial. Plast Reconstr Surg. 2022 Feb 1;149(2):297e-302e. doi: 10.1097/PRS.0000000000008765.

  PMID: 35077429 DERIVED

Study Officials

• Jeffrey A Gusenoff, MD

  UPMC Department of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)