Fat Grafting and Retention for Heel Fat Pad Atrophy

• Status: Completed
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Plantar heel pain is the most common problem of the foot. Plantar fasciitis is the leading cause of this pain, accounting for 11-15% of all foot symptoms seeking professional care, and occurs in 10% of the US population. The cause of heel pain can be from bone, soft tissue, nerve, or systemic disease. The second most common cause of heel pain is fat pad atrophy, followed by a combination of both fat pad atrophy and plantar fasciitis. [1-4] Fat pad displacement may be seen in the heel as well.

Current treatments for plantar fasciitis include stretching and external support with orthotics with the goal of reducing local pressure as well as tissue breakdown.[5] However, patient compliance with extrinsic devices is challenging, and they may experience increased friction, irritation and breakdown at a different location on the foot due to thickness of the device in the shoe. Also, the patient must replace the device as soon as it breaks down but the breakdown often goes unnoticed. Failure of conservative management may lead to treatment with steroids or surgical intervention by endoscopic plantar fasciotomy, open fasciotomy or excision of bone spurs. Injection of steroids can instigate or exacerbate pre-existing heel fat pad atrophy. Autologous fat grafting to the heel may reduce plantar pressures, and thus serve as a treatment for heel pain. Autologous fat grafting is currently under investigation for a myriad of clinical scenarios.[6-19] Even though autologous fat grafting is not yet an established therapeutic approach for the cited indications, some of the reported results have been intriguing.[19] The variable resorption of fat, however, is an important confounding factor in all these studies. Currently the literature reports fat retention rates ranging from 25% to 80%.[20]

The specific aim of this study is to assess the adipose stem cell characteristics in patients undergoing autologous fat grafting for heel fat pad atrophy and correlate these characteristics with fat retention. Data from this study will help determine the characteristics of the adipose stem cells in this population and open the door to additional studies. This pilot study will also help build new collaborative efforts between Foot and Ankle Specialists, Plastic Surgery, and Adipose Stem Cell Biologists, combining biomechanical expertise with fat grafting and basic science expertise.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Anesthetics; Anesthetics, Local; Epinephrine; Epinephryl borate; Lidocaine; Racepinephrine

Criteria

Inclusion Criteria:

• Aged 18 years or older and able to provide informed consent

• Patients with foot pain at the plantar surface of the foot near the head of the metacarpals

• 6 months post any surgical intervention to the foot

• Willing and able to comply with follow up examinations, including ultrasounds and pedobarographic studies

Exclusion Criteria:

• Age less than 18 years

• Inability to provide informed consent

• Feet with open ulcerations or osteomyelitis

• Poorly controlled Diabetics with hemoglobinA1C > 7.

• Active infection anywhere in the body

• Diagnosed with 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 anesthesia, unsafe to the patient.

• Pregnancy

• Subjects with a diagnosis of Schizophrenia or Bipolar Disorder (Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion).

• Tobacco use: Last use within 1 year per patient report