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NCT01645722 · ClinicalTrials.gov registry record · NA
Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites
A NA study of Pain and Amputation Stumps, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT01645722 is a NA study of Pain and Amputation Stumps that has completed, run by University of Pittsburgh. The registered enrollment target is 5 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01645722, a NA study of Pain and Amputation Stumps, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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. 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
Conditions Studied
Interventions
- PROCEDURE Procedure/Surgery: Enriched Fat grafting
Study Locations (1)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-09-14 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01645722
The ClinicalTrials.gov registry entry for NCT01645722 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (98% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Procedure/Surgery: Enriched Fat grafting is the first listed.
NCT01645722 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01645722 about?
NCT01645722 is a clinical study titled "Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites". 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 mi...
What is the current status of trial NCT01645722?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2012-07. Estimated completion is 2016-09-14.
What conditions does trial NCT01645722 study?
This clinical trial studies the following conditions: Pain, Amputation Stumps.
What interventions are being tested in trial NCT01645722?
The interventions under investigation include: Procedure/Surgery: Enriched Fat grafting (PROCEDURE).
Who is sponsoring clinical trial NCT01645722?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01645722 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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