AMP30: Autologous Fat Grafting, Amputation Sites Pain: Randomized

Completed · Not applicable

Conditions studied: Wounded Warrior, Limb Shortening, Amputation

In brief

We propose a prospective, randomized clinical study to assess the efficacy of minimally invasive autologous fat transfer addressing pain and poor prosthetic fit at amputation sites.

Key facts

Study ID

NCT02076022

Run by

J. Peter Rubin, MD

People needed

10

Starts

2014-04-08

Expected to finish

2019-01-28

Last updated by the study team

2020-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years or older and able to provide informed consent
• Has 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 and/or Have an amputation with pain that limits the use of an assistive device(s) despite maximal attempts to change the design of use of the device
• 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
• Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits
• Subjects with residual limb problems including upper and lower limb loss, and/or individuals with partial hand, partial foot and more proximal injuries.
• Subjects with Intolerability that may include appropriate soft tissue padding, soft tissue coverage, or pain that doesn't allow the consistent wearing of a prosthetic socket. (This may include excessive pain, inability to achieve adequate suspension of prosthesis on the individual, continual skin breakdown, excessive pressure/shear on skin, soft tissue, nerves, scars, etc.) and/or Subjects with Intolerability that limits use of an assistive device(s) that aid mobility of daily living activities involving the functional use of affected limb.
• Subjects who are unable to consistently wear a prosthetic socket must have received a minimum of 3 months of unsuccessful prosthetic fitting trials. This will include a minimum of at least 5 different socket adjustments. This can include re-casting the residual limb, providing pressure relieves within the socket, changing the alignment of the prosthetic components to alter ground reactive forces, and adding padding to pressure sensitive areas. Likewise, subjects using assistive devices must have received a minimum of 3 months of unsuccessful assistive device adjustments. This information pertaining to the history of prosthetic fit attempts may be received from referral physician, prosthetics and/or orthotics direct report and/or subject self-report and/or medical record review.
• Subjects should have an approximate range of the defect volume between 5cc to as much as 300cc. if the defect is a very local soft tissue deficiency over a pressure point. (The volume of the defect correlates with moderate or severe intolerability of the prosthesis)
• Subjects must have a current relationship with a prosthetist and/or Assistive device Technician.
• Subjects who have a history of cancer to an affected limb that results in a surgical amputation maybe eligible.
• Subjects who have a history of embolus to the affected limb that results in surgical amputation maybe eligible

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 or tunneling
• Active drainage or 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 (e.g., scleroderma, lupus, vasculatures, collagen disease etc.)
• Pregnancy
• History of Diabetes Mellitus
• History of severe peripheral arterial disease
• Subjects with an Axis I DSM-IV diagnosis (e.g., Schizophrenia, Bipolar disorder) who are found to be clinically (i.e. medically) unstable at baseline. Individuals who manifest either: 1) evidence of currently active alcohol or psychoactive drug abuse or dependence on the SCID interview, or 2) a GAF score of 40 or lower due to any acute psychiatric symptomatology (e.g. suicidality, psychosis, severe depression or mania) will be reviewed by the Co-I for Psychosocial Assessment with the PI for determination of possible medical instability. Final determination of medically unstable status will be made by the PI on the basis of overall medical status and appropriateness for medical procedures; the patient may be considered ineligible for study participation per the Physician's discretion.
• Subjects with abnormal blood biochemistry or any other abnormal laboratory finding considered clinically significant in that it would deem the subject inappropriate for surgical procedures. This criterion will help to exclude subjects with severe nutritional deficiency, anemia, coagulopathy, renal and liver dysfunction, diabetes, and peripheral vascular disease, as determined by the investigator (i.e. CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests). As general safety measures, we will exclude patients with lab values listed below: Hct less than 30% INR greater than 1.8 Creatinine greater than 2.0 Liver function tests (ALT, AST, Bilirubin) greater than 2 times upper limit Albumin- Less than 2.0 Platelets less than 70
• Subjects who per the clinical discretion of the investigator, would not be appropriate for the study. (e.g. a potential medication and/ or medical diagnosis that is not captured in above exclusion, but which could render the subject's participation in the study unsafe, or would have an adverse effect on fat metabolism or fat healing).

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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