Perforating Fat Injections for Plantar Fasciosis

Not Applicable

Completed

• Conditions: Plantar Fascia
• Interventions: Procedure: Fat Grafting

• Registration Number: NCT02855983
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-04
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A (Fat grafting initially)	Fat Grafting	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.
B (Standard of care initially)	Fat Grafting	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.

Primary Outcome Measures

Name	Time	Method
Plantar fascia thickness	6 months	Assessed by ultrasound

Secondary Outcome Measures

Name	Time	Method
Plantar foot pain	6 months	Assessed by validated foot pain questionnaries
Local and systemic complications resulting from fat graft procedure	6 months	Including infection, fat necrosis, hematoma, seroma

Trial Locations

Locations (1)

UPMC Plastic Surgery Aesthetic Center; 🇺🇸 Pittsburgh, Pennsylvania, United States