Fat Grafting for Pedal Fat Pad Atrophy in Diabetics
Cuvinte cheie
Abstract
Descriere
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.
Datele
| Ultima verificare: | 03/31/2018 |
| Primul depus: | 02/25/2014 |
| Inscriere estimată trimisă: | 02/25/2014 |
| Prima postare: | 02/27/2014 |
| Ultima actualizare trimisă: | 04/01/2018 |
| Ultima actualizare postată: | 04/03/2018 |
| Data actuală de începere a studiului: | 10/31/2013 |
| Data estimată de finalizare primară: | 03/31/2018 |
| Data estimată de finalizare a studiului: | 03/31/2018 |
Stare sau boală
Intervenție / tratament
Procedure: YEAR A PATHWAY
Procedure: Year B Pathway
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Active Comparator: 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:
Post op Visit 1 (2 weeks +/- 5 days)
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 YEAR B PathWay
Post op study visit 6 (18 months)
Post op study visit 7 (24 months) | Procedure: YEAR A PATHWAY Fat Grafting Operative Procedure followed by Standard of Care Follow-up. |
| Active Comparator: Year B Pathway Observational visits at 6 and 12 months with fat grafting procedures during year 2.
Study visit 1 (month 6)
Study Visit 2 (month 12)
Collection of subject's medication profile, vital signs (Temp, HR, Resp, BP), and weight to calculate BMI,
Limited physical exam with a foot exam completed by the PI and /or the Coinvestigator
Adverse Event Reporting
Ultrasound
Pedobarograph
2D Photographs
Foot Pain Assessment Questionnaire
Medical chart review including review of records from SOC podiatrists
Operative Visit Followed by Post op study visits 2-5 as described in Year A Pathway | Procedure: Year B Pathway Standard of Care Followed by Fat Grafting Operative 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 - 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 |
Rezultat
Măsuri de rezultate primare
1. Durability of Relief and reduction of foot pressure [24 months]
Măsuri de rezultate secundare
1. Measurement of pedal pressure and plantar tissue thickness [24 months]
2. Measurement of durability of fat grafting vs silicone or other fillers [24 Months]
3. Assessment of pain and skin lesions [24 months]
