Fat Grafting for Pedal Fat Pad Atrophy in Diabetics

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:

1. Post op Visit 1 (2 weeks +/- 5 days)
2. Post op study visit 2 (1 month)
3. Post op study visit 3 (2 month)
4. Post op study visit 4 (6 month)
5. Post op study visit 5 (12 month) CROSSOVER to YEAR B PathWay
6. Post op study visit 6 (18 months)
7. Post op study visit 7 (24 months)

• Fat Grafting Operative Porcedure

Observational visits at 6 and 12 months with fat grafting procedures during year 2.

1. Study visit 1 (month 6)

2. Study Visit 2 (month 12)

   1. Collection of subject's medication profile, vital signs (Temp, HR, Resp, BP), and weight to calculate BMI,
   2. Limited physical exam with a foot exam completed by the PI and /or the Coinvestigator
   3. Adverse Event Reporting
   4. Ultrasound
   5. Pedobarograph
   6. 2D Photographs
   7. Foot Pain Assessment Questionnaire
   8. Medical chart review including review of records from SOC podiatrists
3. Operative Visit Followed by Post op study visits 2-5 as described in Year A Pathway

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

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.

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.