ClinicalTrials.gov
ClinicalTrials.gov Menu

Fat Grafting and Retention for Heel Fat Pad Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02465333
Recruitment Status : Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey A. Gusenoff, MD, University of Pittsburgh

Brief Summary:

Plantar heel pain is the most common problem of the foot. Plantar fasciitis is the leading cause of this pain, accounting for 11-15% of all foot symptoms seeking professional care, and occurs in 10% of the US population. The cause of heel pain can be from bone, soft tissue, nerve, or systemic disease. The second most common cause of heel pain is fat pad atrophy, followed by a combination of both fat pad atrophy and plantar fasciitis. [1-4] Fat pad displacement may be seen in the heel as well.

Current treatments for plantar fasciitis include stretching and external support with orthotics with the goal of reducing local pressure as well as tissue breakdown.[5] However, patient compliance with extrinsic devices is challenging, and they may experience increased friction, irritation and breakdown at a different location on the foot due to thickness of the device in the shoe. Also, the patient must replace the device as soon as it breaks down but the breakdown often goes unnoticed. Failure of conservative management may lead to treatment with steroids or surgical intervention by endoscopic plantar fasciotomy, open fasciotomy or excision of bone spurs. Injection of steroids can instigate or exacerbate pre-existing heel fat pad atrophy. Autologous fat grafting to the heel may reduce plantar pressures, and thus serve as a treatment for heel pain. Autologous fat grafting is currently under investigation for a myriad of clinical scenarios.[6-19] Even though autologous fat grafting is not yet an established therapeutic approach for the cited indications, some of the reported results have been intriguing.[19] The variable resorption of fat, however, is an important confounding factor in all these studies. Currently the literature reports fat retention rates ranging from 25% to 80%.[20]

The specific aim of this study is to assess the adipose stem cell characteristics in patients undergoing autologous fat grafting for heel fat pad atrophy and correlate these characteristics with fat retention. Data from this study will help determine the characteristics of the adipose stem cells in this population and open the door to additional studies. This pilot study will also help build new collaborative efforts between Foot and Ankle Specialists, Plastic Surgery, and Adipose Stem Cell Biologists, combining biomechanical expertise with fat grafting and basic science expertise.


Condition or disease Intervention/treatment Phase
Heel Fat Pad Atrophy Procedure: Heel Fat Grafting Drug: Local anesthetic Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fat Grafting and Retention for Heel Fat Pad Atrophy
Study Start Date : May 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Pathway A

Screening visit followed by heel 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)

Procedure: Heel Fat Grafting

Fat grafting is widely used by plastic surgeons and is considered a standard of care procedure in plastic surgery. Fat tissue to be used for grafting is harvested with a small liposuction cannula. The fat is then centrifuged, cleaned, and loaded into 1cc syringes and injected into the heel fat pad using specialized 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.


Drug: Local anesthetic

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.

Other Names:
  • Lidocaine
  • Epinephrine

Pathway B

Screening visit followed by:

Study visit 1 (6 months) Study Visit 2 (12 months) Crossover to Pathway A

Heel 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)

Procedure: Heel Fat Grafting

Fat grafting is widely used by plastic surgeons and is considered a standard of care procedure in plastic surgery. Fat tissue to be used for grafting is harvested with a small liposuction cannula. The fat is then centrifuged, cleaned, and loaded into 1cc syringes and injected into the heel fat pad using specialized 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.


Drug: Local anesthetic

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.

Other Names:
  • Lidocaine
  • Epinephrine




Primary Outcome Measures :
  1. Pedobarograph to measure foot pressure [ Time Frame: baseline and 2 years ]
    Change in foot pressure will be measured on the pedobarograph in kg/cm2 or psi. These measures will be performed before and after treatment with fat grafting to assess changes over time.


Secondary Outcome Measures :
  1. Adipose stem cell counts [ Time Frame: baseline and 2 years ]
    Extra fat from the liposuction procedure will be sent for adipose stem cell analysis to correlate to retention of the fat over time.

  2. Ultrasound to measure tissue thickness [ Time Frame: baseline 2 years ]
    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.

  3. Manchester Foot Disability Index for pain [ Time Frame: baseline and 2 years ]
    Pain will be evaluated with the Manchester Foot Disability Index.These measures will be performed before and after treatment with fat grafting to assess changes over time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • Age less than 18 years
  • Inability to provide informed consent
  • Feet with open ulcerations or osteomyelitis
  • Poorly controlled Diabetics with hemoglobinA1C > 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465333


Locations
United States, Pennsylvania
UPMC Department of Plastic Surgery
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Jeffrey A Gusenoff, MD University of Pittsburgh

Publications:

Responsible Party: Jeffrey A. Gusenoff, MD, Associate Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02465333     History of Changes
Other Study ID Numbers: PRO14110358
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeffrey A. Gusenoff, MD, University of Pittsburgh:
heel
atrophy
fat
adipose tissue
fat pad

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Lidocaine
Anesthetics, Local
Anesthetics
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents