Fat Grafting for Pedal Fat Pad Atrophy
Cuvinte cheie
Abstract
Descriere
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.
Datele
| Ultima verificare: | 03/31/2017 |
| Primul depus: | 02/17/2013 |
| Inscriere estimată trimisă: | 02/20/2013 |
| Prima postare: | 02/21/2013 |
| Ultima actualizare trimisă: | 02/11/2018 |
| Ultima actualizare postată: | 02/13/2018 |
| Data actuală de începere a studiului: | 02/28/2013 |
| Data estimată de finalizare primară: | 03/31/2017 |
| Data estimată de finalizare a studiului: | 03/31/2017 |
Stare sau boală
Intervenție / tratament
Procedure: Pedal Fat Grafting
Other: Local anesthetic
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Other: Pathway A Screening visit followed by pedal fat grafting procedure with local anesthetic and visits at:
1 week
Post op study visit 2 (1 month)
Post op study visit 3 (2 month)
Post op study visit 4 (6 month)
Post op study visit 5 (12 month)
Crossover to standard podiatry visits
Study visit 6 (18 months)
Study visit 7 (24 months) | |
| Other: Pathway B Screening visit followed by:
Study visit 1 (6months)
Study Visit 2 (12 months)
Crossover to Pathway A
pedal fat grafting procedure and local anesthetic and visits at:
1 week
Post op study visit 2 (1 month post procedure)
Post op study visit 3 (2 month post procedure)
Post op study visit 4 (6 month post procedure)
Post op study visit 5 (12 month post procedure) |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | All |
| Acceptă voluntari sănătoși | da |
| Criterii | 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 - 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 |
Rezultat
Măsuri de rezultate primare
1. Demonstrate that autologous fat grafting decreases pedal pressure during gait and increase plantar tissue thickness. [1-2 years]
Măsuri de rezultate secundare
1. Autologous fat grafting will demonstrate durability over time due to its biologic compatibility [1-2 years]
Alte măsuri de rezultat
1. With decreased pedal pressure and increased tissue thickness, pain and skin lesions will be reduced in patients with metatarsalgia [1-2 years]
