Fat Grafting for Pedal Fat Pad Atrophy

Not Applicable

Completed

• Conditions: Pedal Fat Pad Atrophy
• Interventions: Procedure: Pedal Fat Grafting; Other: Local anesthetic

• Registration Number: NCT01796808
• Lead Sponsor: University of Pittsburgh

Brief Summary

It is believed that the average person with an eighty year old life span will walk the distance of the world twice in their lifetime. The foot is comprised of a specialized fat pad to provide shock absorption and protection against breakdown. With all the walking humans do however, foot fat pad breakdown is inevitable. Trauma to the foot is compounded in the diabetic patients due to many reasons: loss of protective sensation secondary to neuropathy, reduced skin hydration, decreased soft tissue elasticity, elevated blood sugars and increased body weight to name a few. Increased foot pressure and decreased fat pad protection are the main contributing factors to callus formation, foot pain and ulcer formation.

Fat grafting is a cosmetic and reconstructive procedure that is used sometimes to help improve one's soft tissue thickness, shape and integrity. Autologous fat transplantation is a procedure using a patient's own fat that is taken by a small liposuction tube, from areas with a substantial amount of fat ( i.e. abdomen or thighs) and then transferred into the fat atrophied (decreased or worn out) area (in this case, the foot).

The investigators are performing this research in an effort to decrease foot pressure during activity and to increase the soft tissue thickness of the sole of the foot during one's lifetime. Ultimately this could help reduce foot pain, callus formation and even ulcer formation. The goal of this research is to see whether fat grafting will help decrease the prevalence of the aforementioned foot complications. The investigators hope that by using one's own fat tissue, he or she may have a longer duration of relief than by using other methods.

This is a randomized, cross-over designed study. Randomized means that patients will be enrolled by chance (like the flip of a coin) to one of two groups for the first part of the study. Cross-over means that, after the first part of the study or at one year, patients will move into the opposite group. One group will receive the fat grafting procedure with one year follow up (year A pathway) and the other will receive standard of care treatment from the patient's primary podiatrist during the first year (year B pathway). After the first year, patients will switch to the opposite year pathway for the next 12 months. Participation in this study will last approximately 24-26 months.

Detailed Description

The etiology of plantar fat pad atrophy may be age-related, due abnormal foot mechanics, steroid use, or collagen vascular disease. Displacement or atrophy of the fat pad can lead to osseous prominences in the forefoot that may be seen with painful skin lesions. Disease states, such as diabetes, may have loss of soft tissue integrity. Fat pad atrophy, regardless of the etiology, may result in significant pain, epidermal lesions, or metatarsalgia. In sensate patients, the pain can lead to emotional and physical pain, leading to productivity and financial losses.1

It is well documented that plantar pressure is directly correlated with plantar tissue thickness, with the loss of plantar fat being a fundamental mechanism for pressure related foot disorders.2,3 Autologous fat grafting to areas of plantar fat pad atrophy may reduce plantar pressures, and thus serve as a treatment for metatarsalgia, corn and callus prevention, and possibly ulcer prevention in diabetics. Plastic surgeons, with significant skills in fat grafting, can make a significant contribution.

Current treatment modalities for fat pad atrophy include silicone injections, fat injections, and other temporary fillers; however, no objective studies using autologous fat have been performed. Approximately 30 adults who experience pain from fat pad atrophy, will have the option to participate. Through a randomized, controlled, cross-over study, some patients will receive autologous fat grafting, while some will receive standard of care podiatric treatment, then cross-over to fat grafting treatment after a year. Through pedobarograph and ultrasound assessments, the focal pedal pressure and tissue thickness following treatment will be documented over two years.

The investigators hypothesize that fat grafting for areas of increased pedal pressure will help decrease foot pressure during gait and increase soft tissue thickness on the foot pad, ultimately reducing pain. The investigators also hope to demonstrate that by using autologous fat with evidence-based fat transfer techniques, results may be durable. This pilot study will help build new collaborative efforts between Foot and Ankle Surgery, Podiatry and Plastic Surgery, combining expertise in foot biomechanics with reconstructive fat grafting.

Study Timeline

• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-22
• Study Start: 2013-03
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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Exclusion Criteria

• Age less than 18 years
• Inability to provide informed consent
• Feet with open ulcerations or osteomyelitis
• Diabetics: Type I and II
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pathway B	Pedal Fat Grafting	Screening visit followed by: 1. Study visit 1 (6months) 2. Study Visit 2 (12 months) 3. Crossover to Pathway A pedal fat grafting procedure and local anesthetic and visits at: 1. 1 week 2. Post op study visit 2 (1 month post procedure) 3. Post op study visit 3 (2 month post procedure) 4. Post op study visit 4 (6 month post procedure) 5. Post op study visit 5 (12 month post procedure)
Pathway B	Local anesthetic	Screening visit followed by: 1. Study visit 1 (6months) 2. Study Visit 2 (12 months) 3. Crossover to Pathway A pedal fat grafting procedure and local anesthetic and visits at: 1. 1 week 2. Post op study visit 2 (1 month post procedure) 3. Post op study visit 3 (2 month post procedure) 4. Post op study visit 4 (6 month post procedure) 5. Post op study visit 5 (12 month post procedure)
Pathway A	Pedal Fat Grafting	Screening visit followed by pedal fat grafting procedure with local anesthetic and visits at: 1. 1 week 2. Post op study visit 2 (1 month) 3. Post op study visit 3 (2 month) 4. Post op study visit 4 (6 month) 5. Post op study visit 5 (12 month) 6. Crossover to standard podiatry visits 7. Study visit 6 (18 months) 8. Study visit 7 (24 months)
Pathway A	Local anesthetic	Screening visit followed by pedal fat grafting procedure with local anesthetic and visits at: 1. 1 week 2. Post op study visit 2 (1 month) 3. Post op study visit 3 (2 month) 4. Post op study visit 4 (6 month) 5. Post op study visit 5 (12 month) 6. Crossover to standard podiatry visits 7. Study visit 6 (18 months) 8. Study visit 7 (24 months)

Primary Outcome Measures

Name	Time	Method
Demonstrate that autologous fat grafting decreases pedal pressure during gait and increase plantar tissue thickness.	1-2 years	Pressure will be measured on the pedobarograph in kg/cm2 or psi. Tissue thickness will be measured by ultrasound as mm. These measures will be performed before and after treatment with fat grafting to assess changes over time.

Secondary Outcome Measures

Name	Time	Method
Autologous fat grafting will demonstrate durability over time due to its biologic compatibility	1-2 years	Autologous fat grafting will demonstrate durability over time due to its biologic compatibility. Durability will be assessed via tissue thickness (ultrasound; mm), pressure (pedobarograph; psi), and pain score (validated Manchester Foot Pain Disability Index).

Trial Locations

Locations (1)

UPMC Department of Plastic Surgery; 🇺🇸 Pittsburgh, Pennsylvania, United States