Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites

Completed · Not applicable

Conditions studied: Amputation Stumps, Pain

In brief

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.

Key facts

Study ID

NCT01645722

Run by

University of Pittsburgh

People needed

5

Starts

2012-07-01

Expected to finish

2016-09-14

Last updated by the study team

2017-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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