Fat Grafting for Pedal Fat Pad Atrophy in Diabetics
Pedal Pad Atrophy, Diabetes Mellitus
About this trial
This is an interventional treatment trial for Pedal Pad Atrophy
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
Sites / Locations
- University of Pittsburgh Department of Plastic Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
YEAR A PATHWAY
Year B 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)
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