Perforating Fat Injections for Plantar Fasciosis

NCT ID: NCT02855983

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-12-31

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.

Conditions

Plantar Fascia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fat Grafting

Intervention Type: 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.

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.

Group Type: OTHER

Fat Grafting

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey A. Gusenoff, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey A Gusenoff, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Department of Plastic Surgery

Locations

UPMC Plastic Surgery Aesthetic Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35077429 (View on PubMed)

Other Identifiers

UPittsburgh_PRF

Identifier Type: -

Identifier Source: org_study_id