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Trial record 1 of 1 for:    Perforating Fat Injections for Plantar Fasciosis (PRF)
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Perforating Fat Injections for Plantar Fasciosis (PRF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02855983
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey A. Gusenoff, MD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Plantar Fascia Procedure: Fat Grafting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perforating Fat Injections for Plantar Fasciosis
Study Start Date : August 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: A (Fat grafting initially)

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
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.

B (Standard of care initially)

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
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.




Primary Outcome Measures :
  1. Plantar fascia thickness [ Time Frame: 6 months ]
    Assessed by ultrasound


Secondary Outcome Measures :
  1. Local and systemic complications resulting from fat graft procedure [ Time Frame: 6 months ]
    Including infection, fat necrosis, hematoma, seroma

  2. Plantar foot pain [ Time Frame: 6 months ]
    Assessed by validated foot pain questionnaries



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Patients meeting the following criteria will be eligible to participate in the study:

  1. Aged 18 years or older and able to provide informed consent
  2. Subjects with a diagnosis of Plantar Fasciitis having heel pain that has not improved with splints, exercises or rountine standard of care treatment
  3. Subjects must have a current relationship with their foot specialist managing the Plantar Fasciitis diagnosis.
  4. Subjects must be 6 months post any surgical intervention to the affected foot
  5. 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.
  6. Willing and able to comply with follow up examinations, including ultrasounds and radiographs
  7. 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.

Exclusion Criteria:

Patients with the following characteristics will be excluded from participating in the study:

  1. Age less than 18 years
  2. Inability to provide informed consent
  3. Bilateral foot examination presents with open ulcerations, or diagnosis of osteomyelitis, non-healed fracture, neuropathy or tarsal tunnel syndrome.
  4. Diabetics with a HgA1C >7
  5. 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.
  6. Diagnosed with systemic or metastatic cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
  7. Known coagulopathy
  8. Systemic disease that would render the fat harvest and injection procedure, along with associated local anesthetic unsafe to the patient.
  9. 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. )
  10. Diagnosis of Pregnancy or the intent to of the participant to become pregnant during her participation in this study
  11. 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).
  12. 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.
  13. Morbid obesity: BMI>than or equal to 40

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855983


Locations
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United States, Pennsylvania
UPMC Plastic Surgery Aesthetic Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Jeffrey A Gusenoff, MD UPMC Department of Plastic Surgery
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Responsible Party: Jeffrey A. Gusenoff, MD, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02855983    
Other Study ID Numbers: UPittsburgh_PRF
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes