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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plantar fascia thickness | Assessed by ultrasound | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local and systemic complications resulting from fat graft procedure | Including infection, fat necrosis, hematoma, seroma | 6 months |
| Plantar foot pain | Assessed by validated foot pain questionnaries |
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Inclusion Criteria
Patients meeting the following criteria will be eligible to participate in the study:
Exclusion Criteria:
Patients with the following characteristics will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey A Gusenoff, MD | UPMC Department of Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Plastic Surgery Aesthetic Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35077429 | Derived | 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. |
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| 6 months |