Fat Grafting for Pedal Fat Pad Atrophy in Diabetics
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 2013 |
| End Date: | April 2018 |
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.
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.
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.
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.
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
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