Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites

NCT01645722 | Completed DMC

• 1 other identifier: PRO11090215
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is to assess the efficacy of minimally invasive autologous fat transfers at the amputation sites and the modulation of pain at the respective sites. Our investigators hypothesize that autologous fat grafting can provide a minimally invasive therapy to effectively mitigate pain syndromes at amputation sites, by introducing volume stable subcutaneous tissue over bony prominences and peripheral nerve trunks, thereby avoiding major surgical revisions and preserving limb length. The investigators further hypothesize that enriching the fat graft with autologous adipose stromal cells, a regenerative medicine approach, will lead to improved retention of the fat graft over time and result in a more favorable outcome. The Investigators will evaluate:

1. 1.Treatment of painful amputation sites in 5 patients with fat grafting, intended to provide additional subcutaneous tissue padding over bony structures and nerve trunks. Limb anatomy and healing of the graft over time, along with stability/persistence of the new tissue, will be assessed by high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes. Patients will be enrolled who have pain at an amputation site that limits function and/or interferes with the ability to use a prosthesis.
2. 2.Biologic properties of the cells within the fat graft and correlate with clinical outcomes. This will include adipose stem cell yield per volume of fat tissue, cell proliferation, capacity for adipogenic differentiation, lipolysis, and cell sub-population analysis by multiparameter flow cytometry. Results of these assays will be correlated with graft volume retention to search for predictors of good clinical outcome that are related to variation on adipose biology between subjects.
3. 3.Quality of life measurements in patients before and after autologous fat grafting using validated psychosocial measures. This will include SF 36, the Beck inventory, and instruments designed for assessing limb function.

Conditions

Amputation Stumps; Pain

Keywords

Fat Grafts; Autogenous Fat Transfers (AFT); Wounded warriors; Amputation pain

Outcome Measures

Primary Outcomes (1)

• Treatment of Painful Amputation Sites

  1\) Treat painful amputation sites in 5 patients with fat grafting, to provide additional subcutaneous tissue padding over bony structures and nerve trunks. Limb anatomy and healing of the graft over time, along with stability/persistence of the new tissue, will be assessed by high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes. Patients will be enrolled who have pain at an amputation site that limits function and/or interferes with the ability to use a prosthesis.

  26 months

Secondary Outcomes (2)

• Assessment of biological cell properties within fat graft

  20 years

• Quality of Life improvement

  26 months

Study Arms (1)

Procedure/Surgery: Enriched Fat grafting

OTHER

Enriched Fat grafting

Procedure: Procedure/Surgery: Enriched Fat grafting

Interventions

Procedure/Surgery: Enriched 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. Fat tissue to be used for grafting is harvested (usually from abdomen or thighs) in the operating room. 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 injected into the amputation stump.In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient.

Also known as: Fat Grafts, Autogenous Fat Transfers (AFT), Wounded warriors, Amputation site pain, Amputation pain

Procedure/Surgery: Enriched Fat grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older and able to provide informed consent
• Have suffered injury resulting in an amputation with pain that limits the fitting and use of a prosthesis, despite maximal attempts to refit the prosthesis and/or change the design of the prosthesis
• Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
• Soft tissue deficiencies are noted at amputation stump and are covered by intact skin
• Willing and able to comply with follow up examinations, including radiographic studies
• Active military
• Able to provide informed consent

You may not qualify if:

• Age less than 18 years
• Patient has inability to provide informed consent process.
• Amputated limb area intended for treatment has open wounds, tunneling or drainage with active infection unresolved with one course of antibiotic treatment.
• Active infection anywhere in the body
• Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
• Known coagulopathy symptoms /diagnosis
• Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
• Pregnancy
• History of Diabetes Mellitus
• History of severe peripheral arterial disease
• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (15)

• Kuntscher MV, Erdmann D, Homann HH, Steinau HU, Levin SL, Germann G. The concept of fillet flaps: classification, indications, and analysis of their clinical value. Plast Reconstr Surg. 2001 Sep 15;108(4):885-96. doi: 10.1097/00006534-200109150-00011.

  PMID: 11547143 BACKGROUND

• Jensen TS, Krebs B, Nielsen J, Rasmussen P. Phantom limb, phantom pain and stump pain in amputees during the first 6 months following limb amputation. Pain. 1983 Nov;17(3):243-256. doi: 10.1016/0304-3959(83)90097-0.

  PMID: 6657285 BACKGROUND

• Stinner DJ, Burns TC, Kirk KL, Scoville CR, Ficke JR, Hsu JR; Late Amputation Study Team. Prevalence of late amputations during the current conflicts in Afghanistan and Iraq. Mil Med. 2010 Dec;175(12):1027-9. doi: 10.7205/milmed-d-10-00102.

  PMID: 21265314 BACKGROUND

• Perrot P, Bouffaut AL, Perret C, Connault J, Duteille F. Risk factors and therapeutic strategy after failure of free flap coverage for lower-limb defects. J Reconstr Microsurg. 2011 Mar;27(3):157-62. doi: 10.1055/s-0030-1268855. Epub 2010 Nov 23.

  PMID: 21104612 BACKGROUND

• Weinberg MJ, Al-Qattan MM, Mahoney J. "Spare part" forearm free flaps harvested from the amputated limb for coverage of amputation stumps. J Hand Surg Br. 1997 Oct;22(5):615-9. doi: 10.1016/s0266-7681(97)80359-2.

  PMID: 9752917 BACKGROUND

• Touam C, Rostoucher P, Bhatia A, Oberlin C. Comparative study of two series of distally based fasciocutaneous flaps for coverage of the lower one-fourth of the leg, the ankle, and the foot. Plast Reconstr Surg. 2001 Feb;107(2):383-92. doi: 10.1097/00006534-200102000-00013.

  PMID: 11214053 BACKGROUND

• Goldberg JA, Adkins P, Tsai TM. Microvascular reconstruction of the foot: weight-bearing patterns, gait analysis, and long-term follow-up. Plast Reconstr Surg. 1993 Oct;92(5):904-11.

  PMID: 8415972 BACKGROUND

• Coleman SR, Saboeiro AP. Fat grafting to the breast revisited: safety and efficacy. Plast Reconstr Surg. 2007 Mar;119(3):775-85; discussion 786-7. doi: 10.1097/01.prs.0000252001.59162.c9.

  PMID: 17312477 BACKGROUND

• Spear SL, Wilson HB, Lockwood MD. Fat injection to correct contour deformities in the reconstructed breast. Plast Reconstr Surg. 2005 Oct;116(5):1300-5. doi: 10.1097/01.prs.0000181509.67319.cf.

  PMID: 16217471 BACKGROUND

• Zheng DN, Li QF, Lei H, Zheng SW, Xie YZ, Xu QH, Yun X, Pu LL. Autologous fat grafting to the breast for cosmetic enhancement: experience in 66 patients with long-term follow up. J Plast Reconstr Aesthet Surg. 2008 Jul;61(7):792-8. doi: 10.1016/j.bjps.2007.08.036. Epub 2008 Mar 5.

  PMID: 18321802 BACKGROUND

• Guyuron B, Majzoub RK. Facial augmentation with core fat graft: a preliminary report. Plast Reconstr Surg. 2007 Jul;120(1):295-302. doi: 10.1097/01.prs.0000264399.40701.71.

  PMID: 17572578 BACKGROUND

• Hu S, Zhang H, Feng Y, Yang Y, Han X, Han X, Zhong Y, Shi J. Introduction of an easy technique for purification and injection of autogenous free fat parcels in correcting of facial contour deformities. Ann Plast Surg. 2007 Jun;58(6):602-7. doi: 10.1097/01.sap.0000248110.59452.49.

  PMID: 17522480 BACKGROUND

• Kaufman MR, Bradley JP, Dickinson B, Heller JB, Wasson K, O'Hara C, Huang C, Gabbay J, Ghadjar K, Miller TA. Autologous fat transfer national consensus survey: trends in techniques for harvest, preparation, and application, and perception of short- and long-term results. Plast Reconstr Surg. 2007 Jan;119(1):323-331. doi: 10.1097/01.prs.0000244903.51440.8c.

  PMID: 17255689 BACKGROUND

• Sardesai MG, Moore CC. Quantitative and qualitative dermal change with microfat grafting of facial scars. Otolaryngol Head Neck Surg. 2007 Dec;137(6):868-72. doi: 10.1016/j.otohns.2007.08.008.

  PMID: 18036412 BACKGROUND

• Bourne DA, Thomas RD, Bliley J, Haas G, Wyse A, Donnenberg A, Donnenberg VS, Chow I, Cooper R, Coleman S, Marra K, Pasquina PF, Rubin JP. Amputation-Site Soft-Tissue Restoration Using Adipose Stem Cell Therapy. Plast Reconstr Surg. 2018 Nov;142(5):1349-1352. doi: 10.1097/PRS.0000000000004889.

  PMID: 30511990 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• J.Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: July 20, 2012
• Study Start: July 1, 2012
• Primary Completion: September 14, 2016
• Study Completion: September 14, 2016
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

US (1)