Clinical trial NCT02074683: Fat Grafting for Pedal Fat Pad Atrophy in Diabetics
Official title: Fat Grafting for Pedal Fat Pad Atrophy in Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pedal Pad Atrophy
Diabetes Mellitus
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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.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.

We hypothesize that fat grafting for areas of increased pedal pressure in well-controlled diabetics will help decrease foot pressure during gait and increase soft tissue thickness on the foot pad, ultimately reducing pain. We 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.

Detailed description: Subjects will be randomized to one of two groups and the visit schema for each group is delineated below. The group determination in which the subject will receive either the standard of care treatment or the fat grafting procedure will be determined using the GraphSoft random number generator function.

Subjects will randomized to a group assignment (Either YEAR A PATHWAY with fat grafting procedure during year one or YEAR B PATHWAY with observational visits at 6 and 12 months with fat grafting procedures during year 2).

YEAR A PATHWAY - this occurs after screening visit and upon eligibility determination

YEAR B PATHWAY - this occurs after screening visit and upon eligibility determination. Pre- Operative research visits will occur at month 6 and 12 and will be concurrent to the subject's standard of care treatment. Visits at months 6 and 12 will be performed by a podiatrist as standard of care.

Eligibility 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
* Diabetics: Type I and II with a HgA1C \< or = 7

Exclusion Criteria:

* Age less than 18 years
* Inability to provide informed consent
* Feet with open ulcerations or osteomyelitis
* Diabetics: Type I and II iwth a HgAIC \> 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

Primary outcomes:
measure: Durability of Relief and reduction of foot pressure
timeFrame: 24 months
Secondary outcomes:
measure: Measurement of pedal pressure and plantar tissue thickness
timeFrame: 24 months
measure: Measurement of durability of fat grafting vs silicone or other fillers
timeFrame: 24 Months
measure: Assessment of pain and skin lesions
timeFrame: 24 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Plastic Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jeffrey Gusenoff, MD
role: PRINCIPAL_INVESTIGATOR
References: