Fat Grafting for Pedal Fat Pad Atrophy

NCT01796808 | Completed

• 1 other identifier: PRO12100139
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

It is believed that the average person with an eighty year old life span will walk the distance of the world twice in their lifetime. The foot is comprised of a specialized fat pad to provide shock absorption and protection against breakdown. With all the walking humans do however, foot fat pad breakdown is inevitable. Trauma to the foot is compounded in the diabetic patients due to many reasons: loss of protective sensation secondary to neuropathy, reduced skin hydration, decreased soft tissue elasticity, elevated blood sugars and increased body weight to name a few. Increased foot pressure and decreased fat pad protection are the main contributing factors to callus formation, foot pain and ulcer formation. Fat grafting is a cosmetic and reconstructive procedure that is used sometimes to help improve one's soft tissue thickness, shape and integrity. Autologous fat transplantation is a procedure using a patient's own fat that is taken by a small liposuction tube, from areas with a substantial amount of fat ( i.e. abdomen or thighs) and then transferred into the fat atrophied (decreased or worn out) area (in this case, the foot). The investigators are performing this research in an effort to decrease foot pressure during activity and to increase the soft tissue thickness of the sole of the foot during one's lifetime. Ultimately this could help reduce foot pain, callus formation and even ulcer formation. The goal of this research is to see whether fat grafting will help decrease the prevalence of the aforementioned foot complications. The investigators hope that by using one's own fat tissue, he or she may have a longer duration of relief than by using other methods. This is a randomized, cross-over designed study. Randomized means that patients will be enrolled by chance (like the flip of a coin) to one of two groups for the first part of the study. Cross-over means that, after the first part of the study or at one year, patients will move into the opposite group. One group will receive the fat grafting procedure with one year follow up (year A pathway) and the other will receive standard of care treatment from the patient's primary podiatrist during the first year (year B pathway). After the first year, patients will switch to the opposite year pathway for the next 12 months. Participation in this study will last approximately 24-26 months.

Conditions

Pedal Fat Pad Atrophy

Keywords

pedal; atrophy; fat grafting; adipose tissue

Outcome Measures

Primary Outcomes (1)

• Demonstrate that autologous fat grafting decreases pedal pressure during gait and increase plantar tissue thickness.

  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.

  1-2 years

Secondary Outcomes (1)

• Autologous fat grafting will demonstrate durability over time due to its biologic compatibility

  1-2 years

Other Outcomes (1)

• With decreased pedal pressure and increased tissue thickness, pain and skin lesions will be reduced in patients with metatarsalgia

  1-2 years

Study Arms (2)

Pathway A

OTHER

Screening visit followed by pedal fat grafting procedure with local anesthetic and visits at: 1. 1 week 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) 6. Crossover to standard podiatry visits 7. Study visit 6 (18 months) 8. Study visit 7 (24 months)

Procedure: Pedal Fat Grafting; Other: Local anesthetic

Pathway B

OTHER

Screening visit followed by: 1. Study visit 1 (6months) 2. Study Visit 2 (12 months) 3. Crossover to Pathway A pedal fat grafting procedure and local anesthetic and visits at: 1. 1 week 2. Post op study visit 2 (1 month post procedure) 3. Post op study visit 3 (2 month post procedure) 4. Post op study visit 4 (6 month post procedure) 5. Post op study visit 5 (12 month post procedure)

Procedure: Pedal Fat Grafting; Other: Local anesthetic

Interventions

Pedal Fat Grafting PROCEDURE

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.

Pathway A; Pathway B

Local anesthetic OTHER

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.

Also known as: Lidocaine, Epinephrine

Pathway A; Pathway B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• months post any surgical intervention to the foot
• Willing and able to comply with follow up examinations, including ultrasounds and pedobarographic studies

You may not qualify if:

• Age less than 18 years
• Inability to provide informed consent
• Feet with open ulcerations or osteomyelitis
• Diabetics: Type I and II
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Department of Plastic Surgery

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (17)

• Bowling FL, Metcalfe SA, Wu S, Boulton AJ, Armstrong DG. Liquid silicone to mitigate plantar pedal pressure: a literature review. J Diabetes Sci Technol. 2010 Jul 1;4(4):846-52. doi: 10.1177/193229681000400412.

  PMID: 20663447 BACKGROUND

• Abouaesha F, van Schie CH, Armstrong DG, Boulton AJ. Plantar soft-tissue thickness predicts high peak plantar pressure in the diabetic foot. J Am Podiatr Med Assoc. 2004 Jan-Feb;94(1):39-42. doi: 10.7547/87507315-94-1-39.

  PMID: 14729989 BACKGROUND

• Abouaesha F, van Schie CH, Griffths GD, Young RJ, Boulton AJ. Plantar tissue thickness is related to peak plantar pressure in the high-risk diabetic foot. Diabetes Care. 2001 Jul;24(7):1270-4. doi: 10.2337/diacare.24.7.1270.

  PMID: 11423514 BACKGROUND

• Espinosa N, Brodsky JW, Maceira E. Metatarsalgia. J Am Acad Orthop Surg. 2010 Aug;18(8):474-85. doi: 10.5435/00124635-201008000-00004.

  PMID: 20675640 BACKGROUND

• Boulton AJ, Franks CI, Betts RP, Duckworth T, Ward JD. Reduction of abnormal foot pressures in diabetic neuropathy using a new polymer insole material. Diabetes Care. 1984 Jan-Feb;7(1):42-6. doi: 10.2337/diacare.7.1.42.

  PMID: 6546713 BACKGROUND

• Young MJ, Cavanagh PR, Thomas G, Johnson MM, Murray H, Boulton AJ. The effect of callus removal on dynamic plantar foot pressures in diabetic patients. Diabet Med. 1992 Jan-Feb;9(1):55-7. doi: 10.1111/j.1464-5491.1992.tb01714.x.

  PMID: 1551311 BACKGROUND

• Chairman EL. Restoration of the plantar fat pad with autolipotransplantation. J Foot Ankle Surg. 1994 Jul-Aug;33(4):373-9.

  PMID: 7951190 BACKGROUND

• van Schie CH, Whalley A, Armstrong DG, Vileikyte L, Boulton AJ. The effect of silicone injections in the diabetic foot on peak plantar pressure and plantar tissue thickness: a 2-year follow-up. Arch Phys Med Rehabil. 2002 Jul;83(7):919-23. doi: 10.1053/apmr.2002.33058.

  PMID: 12098150 BACKGROUND

• Pu LLQ, Coleman SR, Cui X, Ferguson REH Jr, Vasconez HC. Autologous fat grafts harvested and refined by the Coleman technique: a comparative study. Plast Reconstr Surg. 2008 Sep;122(3):932-937. doi: 10.1097/PRS.0b013e3181811ff0.

  PMID: 18766062 BACKGROUND

• Kwan RL, Zheng YP, Cheing GL. The effect of aging on the biomechanical properties of plantar soft tissues. Clin Biomech (Bristol). 2010 Jul;25(6):601-5. doi: 10.1016/j.clinbiomech.2010.04.003. Epub 2010 May 8.

  PMID: 20457479 BACKGROUND

• Veves A, Boulton AJ. The optical pedobarograph. Clin Podiatr Med Surg. 1993 Jul;10(3):463-70.

  PMID: 8364849 BACKGROUND

• Walter Stephen Snyder 1909-1977. Health Phys. 1978 Jan;34(1):1-2. No abstract available.

  PMID: 340428 BACKGROUND

• Pow DV, Morris JF. Tunicamycin, puromycin and brefeldin A influence the subcellular distribution of neuropeptides in hypothalamic magnocellular neurones of rat. Cell Tissue Res. 1992 Sep;269(3):547-60. doi: 10.1007/BF00353909.

  PMID: 1423514 BACKGROUND

• Balkin SW. Injectable silicone and the foot: a 41-year clinical and histologic history. Dermatol Surg. 2005 Nov;31(11 Pt 2):1555-9; discussion 1560. doi: 10.2310/6350.2005.31241.

  PMID: 16416638 BACKGROUND

• van Schie CH, Whalley A, Vileikyte L, Wignall T, Hollis S, Boulton AJ. Efficacy of injected liquid silicone in the diabetic foot to reduce risk factors for ulceration: a randomized double-blind placebo-controlled trial. Diabetes Care. 2000 May;23(5):634-8. doi: 10.2337/diacare.23.5.634.

  PMID: 10834422 BACKGROUND

• Niermeijer P, Gips CH. Viral antibodies and the infectivity of serum in hepatitis B. N Engl J Med. 1978 Oct 26;299(17):958. doi: 10.1056/NEJM197810262991721. No abstract available.

  PMID: 692609 BACKGROUND

• Minteer DM, Gusenoff BR, Gusenoff JA. Fat Grafting for Pedal Fat Pad Atrophy in a 2-Year, Prospective, Randomized, Crossover, Single-Center Clinical Trial. Plast Reconstr Surg. 2018 Dec;142(6):862e-871e. doi: 10.1097/PRS.0000000000005006.

  PMID: 30204683 DERIVED

MeSH Terms

Conditions

Atrophy

Interventions

Anesthetics, Local; Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jeffrey A. Gusenoff, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Plastic Surgery

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 22, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: February 14, 2018

Record last verified: 2017-04

Locations

US (1)