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

Pedal Pad Atrophy

Diabetes Mellitus

Fat Grafting Operative Procedure followed by Standard of Care Follow-up.

Year A Pathway

Standard of Care Followed by Fat Grafting Operative Procedure

Year B Pathway

University of Pittsburgh Department of Plastic Medicine

Fat Grafting for Pedal Fat Pad Atrophy in Diabetics

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.

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.

Jeffrey A. Gusenoff, MD

Associate Professor of Surgery

University of Pittsburgh

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)

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)

Pedal Fat Pad Atrophy

Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years and is considered a standard of care procedure in plastic surgery. 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.
Postoperatively, the foot will be bandaged for twenty-four hours and the subject will be advised to limit ambulation. Over the next three weeks, the patient will be instructed to wear a cushioned, supportive sneaker and participate in only activities of normal daily living, with no excessive aerobic activity.

Pedal Fat Grafting

To numb the foot for the fat grafting procedure, lidocaine with epinephrine will be used. This will be injected near the posterior tibial nerve to numb the bottom of the foot.
Local anesthetic of lidocaine with epinephrine will also be used to numb the fat graft harvest site (i.e. abdomen or thigh). This will allow a small incision to make so that tumescent solution can be injected into the area of fat graft harvest. Tumescent solution is a combination of injectible saline, epinephrine and lidocaine that causes numbness and vasoconstriction in the area where the fat will be harvested. This limits pain and bruising during the procedures. Only a very small amount of tumescent should be needed (i.e. <200ml). Only a few cc's of fat are needed for injection into the foot.

Local anesthetic

UPMC Department of Plastic Surgery

Fat Grafting for Pedal Fat Pad Atrophy

Autologous Fat Grafting for Pedal Fat Pad Atrophy

Pressure will be measured on the pedobarograph in kg/cm2 or psi. Tissue thickness will be measured by ultrasound as mm. These measures will be performed before and after treatment with fat grafting to assess changes over time.

Autologous fat grafting will demonstrate durability over time due to its biologic compatibility. Durability will be assessed via tissue thickness (ultrasound; mm), pressure (pedobarograph; psi), and pain score (validated Manchester Foot Pain Disability Index).

Pain will be assessed with the Manchester Foot Pain Disability Index, a validated foot pain questionnaire, and calluses will be assessed by physical exam and 2D photography.

metatarsalgia/atrofiya

Fat Grafting for Pedal Fat Pad Atrophy in Diabetics

Fat Grafting for Pedal Fat Pad Atrophy

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