Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
13 participants
INTERVENTIONAL
2015-05-31
2021-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fat Grafting for Pedal Fat Pad Atrophy in Diabetics
NCT02074683
Perforating Fat Injections for Plantar Fasciosis
NCT02855983
Fat Grafting for Pedal Fat Pad Atrophy
NCT01796808
Volumetric Analysis in Autologous Fat Grafting to the Foot
NCT02638532
Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites
NCT01645722
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Restoring the plantar fat pad with autologous fat grafting has the potential to improve foot function, decrease foot pain, bone pain, and nerve pain in the sensate foot and potentially decrease the incidence of foot ulceration in diabetics. It also serves to increase shock absorption during gait. Research has shown greater viability and cellular function with fat grafts processed using the Coleman technique than with other techniques.\[25\] It is the investigators aim to implement the Coleman technique to increase pedal shock absorption on a long term basis. Increasing shock absorption is prophylactic for reducing calcaneal contusions and stress fractures. By limiting an antalgic, compensatory gait, this will limit injury to the patient's superstructure and/or the contralateral foot and leg, ultimately improving the patient's overall systemic health.
By minimizing high peak plantar pressures through autologous fat transfer, more severe diabetic complications may be minimized. Heel fat pad augmentation may reduce ulcer formation and/or reformation, and reduce the subsequent comorbid conditions of osteomyelitis and amputation. Typically, ulceration due to bone prominence may be best treated by surgical resection of the prominent bone. However, there exists a population of diabetics that will have a greater chance of developing an acute Charcot event post-surgery or transfer lesions that will ultimately break down. Transfer lesions and re-ulceration is considered a common complication after diabetic foot ulcer surgery.\[26\] Also some patients may not be medically stable making an aggressive osseous surgical procedure inadvisable. If autologous fat grafting does prove to be effective in the foot, it could become a concomitant procedure performed with osseous procedures for a target population of diabetics to limit transfer lesions and ulceration post operatively.
If the proposed aims are achieved, patients will be able to have long lasting reconstruction of the heel fat pad with a minimally invasive procedure using autologous tissue. The ultimate costs of maintaining specialized extrinsic padding, shoe gear, and issues with patient compliance can be reduced or eliminated. It could potentially save the medical arena the costs of treating diabetic ulcerations and the resultant complications. The need for other fillers such as silicone which can migrate and involve lymph nodes can be eliminated, as can the need for repeat injections of other temporary fillers which are currently used without any evidence-based medicine. This project will improve scientific knowledge, technical capability, and clinical practice in both the field of plastic surgery and podiatry. Not only will it influence these fields, but augmenting the heel fat pad has the potential to benefit diabetics, geriatric patients, Wounded Warriors with amputations whom have differential loading of their remaining lower extremity, athletes, and cosmetic patients who would like a more active lifestyle than their current foot pain allows.
Determining the intrinsic fat properties that lead to a consistent and high fat retention rate can have an enormous impact on the current clinical field of fat grafting. Over 80,000 autologous fat grafting procedures were documented in 2013 by The American Society for Aesthetic Plastic Surgery.\[27\] Determining the factors related to fat retention can aid surgeons in determining the potential amount of fat that may be necessary for optimizing retention, and potentially avoid need for recurrent treatments. Further on, this data would also allow bioengineers to specifically develop fillers using the constituents known to be of importance for the final retention. This project will increase scientific knowledge, technical capability, and improve clinical collaboration between Foot and Ankle Specialists, Plastic Surgeons, and Adipose Stem Cell Biologists.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
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.
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)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pittsburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jeffrey A. Gusenoff, MD
Associate Professor of Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey A Gusenoff, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UPMC Department of Plastic Surgery
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Chairman EL. Restoration of the plantar fat pad with autolipotransplantation. J Foot Ankle Surg. 1994 Jul-Aug;33(4):373-9.
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.
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.
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.
Veves A, Boulton AJ. The optical pedobarograph. Clin Podiatr Med Surg. 1993 Jul;10(3):463-70.
Walter Stephen Snyder 1909-1977. Health Phys. 1978 Jan;34(1):1-2. No abstract available.
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.
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.
Nicoletti G, Brenta F, Jaber O, Laberinti E, Faga A. Lipofilling for functional reconstruction of the sole of the foot. Foot (Edinb). 2014 Mar;24(1):21-7. doi: 10.1016/j.foot.2014.02.003. Epub 2014 Mar 6.
Hsu CC, Tsai WC, Hsiao TY, Tseng FY, Shau YW, Wang CL, Lin SC. Diabetic effects on microchambers and macrochambers tissue properties in human heel pads. Clin Biomech (Bristol). 2009 Oct;24(8):682-6. doi: 10.1016/j.clinbiomech.2009.06.005. Epub 2009 Jul 19.
Hsu CC, Chen CP, Lin SC, Tsai WC, Liu HT, Lin YC, Lee HJ, Chen WP. Determination of the augmentation effects of hyaluronic acid on different heel structures in amputated lower limbs of diabetic patients using ultrasound elastography. Ultrasound Med Biol. 2012 Jun;38(6):943-52. doi: 10.1016/j.ultrasmedbio.2012.02.031. Epub 2012 Apr 12.
Stupar M, Tibbles A. Heel pain and HIV-associated lipodystrophy: a report of two cases. J Can Chiropr Assoc. 2008 Jun;52(2):103-9.
Campanelli V, Fantini M, Faccioli N, Cangemi A, Pozzo A, Sbarbati A. Three-dimensional morphology of heel fat pad: an in vivo computed tomography study. J Anat. 2011 Nov;219(5):622-31. doi: 10.1111/j.1469-7580.2011.01420.x. Epub 2011 Aug 17.
Yi TI, Lee GE, Seo IS, Huh WS, Yoon TH, Kim BR. Clinical characteristics of the causes of plantar heel pain. Ann Rehabil Med. 2011 Aug;35(4):507-13. doi: 10.5535/arm.2011.35.4.507. Epub 2011 Aug 31.
Uzel M, Cetinus E, Ekerbicer HC, Karaoguz A. Heel pad thickness and athletic activity in healthy young adults: a sonographic study. J Clin Ultrasound. 2006 Jun;34(5):231-6. doi: 10.1002/jcu.20230.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO14110358
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.