Trial record 5 of 84 for:    Open Studies | amputation

Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites (AMP-5)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01645722
First received: March 21, 2012
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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. 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. 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. 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.

Condition Intervention
Amputation Stumps
Pain
Procedure: Procedure/Surgery: Enriched Fat grafting

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Treatment of Painful Amputation Sites [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Assessment of biological cell properties within fat graft [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    Assess biologic properties of cells within the fat graft and correlate with clinical outcomes to 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. Assay results to be correlated with graft volume retention to search for predictors of good clinical outcome that are related to variation on adipose biology between subjects. Banked cells are stored for current assay or assay developed at a FUTURE date for correlation.

  • Quality of Life improvement [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    Measure quality of life 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.


Estimated Enrollment: 5
Study Start Date: July 2012
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Procedure/Surgery: Enriched Fat grafting
Enriched Fat grafting
Procedure: Procedure/Surgery: Enriched Fat grafting
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.
Other Names:
  • Fat Grafts
  • Autogenous Fat Transfers (AFT)
  • Wounded warriors
  • Amputation site pain
  • Amputation pain

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 18 years or older and able to provide informed consent
  2. 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
  3. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
  4. Soft tissue deficiencies are noted at amputation stump and are covered by intact skin
  5. Willing and able to comply with follow up examinations, including radiographic studies
  6. Active military
  7. Able to provide informed consent

Exclusion Criteria:

  1. Age less than 18 years
  2. Patient has inability to provide informed consent process.
  3. Amputated limb area intended for treatment has open wounds, tunneling or drainage with active infection unresolved with one course of antibiotic treatment.
  4. Active infection anywhere in the body
  5. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
  6. Known coagulopathy symptoms /diagnosis
  7. Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
  8. Pregnancy
  9. History of Diabetes Mellitus
  10. History of severe peripheral arterial disease
  11. 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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645722

Contacts
Contact: Carroll Lee, BSN 412-864-2587 mockjl@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Carroll Lee, BSN    412-864-2587    mockjl@upmc.edu   
Principal Investigator: J.Peter Rubin, MD         
Sub-Investigator: Sydney Coleman, MD         
Sub-Investigator: Kacey G Marra, PhD         
Sub-Investigator: Gretchen Haas, PhD         
Sub-Investigator: Jeffrey Gusenoff, MD         
Sub-Investigator: Diana Mermon, MS         
Sub-Investigator: Albert Donnenberg, PhD         
Sub-Investigator: Vera S Donnenberg, PhD         
Sub-Investigator: Rory Cooper, PhD         
Sub-Investigator: Sara Peterson, MBA, CPO         
Sub-Investigator: Patsy Simon, RN, BS         
Sub-Investigator: Annmarie Kelleher, MS, OT, CCRC         
Sub-Investigator: Ian Valerio, MD         
Sub-Investigator: Jenelle Mock, BSN         
Sub-Investigator: Wendy Wakefield, CRNP         
Sub-Investigator: Elizabeth Radomsky, PhD         
Sub-Investigator: Jacqueline Bliley, BS         
Sub-Investigator: Ryan Mitchell, MD         
Sub-Investigator: Mara Yerk, BS         
Sub-Investigator: Caroll Lee, BSN         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: J.Peter Rubin, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: J. Peter Rubin, MD, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01645722     History of Changes
Other Study ID Numbers: PRO11090215
Study First Received: March 21, 2012
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
Fat Grafts
Autogenous Fat Transfers (AFT)
Wounded warriors
Amputation pain

ClinicalTrials.gov processed this record on September 16, 2014