- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02074683
Fat Grafting for Pedal Fat Pad Atrophy in Diabetics
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Department of Plastic Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: YEAR A PATHWAY
Operative Procedure will occur after screening visit. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. In brief, fat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula. The fat tissue is then sterilely centrifuged and allowed to decant before separating the fluid and oil layers from the fat tissue fraction. The aspirated fat is then loaded into 1cc syringes and injected into the plantar fat pad using specialized injection cannulas. Follow-up visits:
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Fat Grafting Operative Procedure followed by Standard of Care Follow-up.
Otros nombres:
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Comparador activo: Year B Pathway
Observational visits at 6 and 12 months with fat grafting procedures during year 2.
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Standard of Care Followed by Fat Grafting Operative Procedure
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Durability of Relief and reduction of foot pressure
Periodo de tiempo: 24 months
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The specific aim of this outcomes study is to assess if fat grafting to areas of increased pedal pressure in well-controlled diabetic patients with metatarsalgia will reduce foot pressure during gait, increase the soft tissue thickness of the foot pad and ultimately reduce pain.
Data from this study will help determine the durability of relief from this treatment and open the doors to additional studies using other modalities.
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24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Measurement of pedal pressure and plantar tissue thickness
Periodo de tiempo: 24 months
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Demonstrate that autologous fat grafting decreases pedal pressure during gait and increase plantar tissue thickness in well-controlled diabetics. Rationale: Studies investigating silicone injections, acellular dermal graft and fat grafting demonstrated an increase in soft tissue thickness for about one year in duration. Only one study of fat transfer to the foot has been published; however, a standardized fat grafting technique was not utilized and no objective data were recorded. Hypothesis: Restoring a diabetic patient's fat pad with an autologous fat graft will decrease p |
24 months
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Measurement of durability of fat grafting vs silicone or other fillers
Periodo de tiempo: 24 Months
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Autologous fat grafting in well-controlled diabetics will demonstrate durability over time due to its biologic compatibility. Rationale: Silicone and dermal grafts are foreign materials. Adipose tissue is abundant, inexpensive, biologically compatible and easy to harvest. The Coleman technique has refined fat graft harvesting and shows greater viability and cellular function after transplantation. This technique has not been assessed in plantar fat pad fat grafting. Hypothesis: Fat grafting to the foot employing the Coleman technique will maintain a greater longevity of success compared to historical studies of silicone or other fillers. |
24 Months
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Assessment of pain and skin lesions
Periodo de tiempo: 24 months
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With decreased pedal pressure and increased tissue thickness, pain and skin lesions will be reduced in well-controlled diabetic patients with metatarsalgia. Rationale: Plantar fat pad atrophy and limited joint mobility are risk factors increasingly associated with high foot pressures and, ultimately, pain and onset of skin lesions. Hypothesis: Increasing soft tissue thickness and decreasing pedal pressure through autologous fat transfer in well-controlled diabetics will reduce skin lesion formation and decrease foot pain. |
24 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeffrey Gusenoff, MD, University of Pittsburgh
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PRO13080186
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