Wounded WarriorAMP30NCT02076022
AMP30: Autologous Fat Grafting, Amputation Sites Pain: Randomized
A study testing Enhanced Fat Grafting and Standard fat graft in people with Wounded Warrior and Limb Shortening, run by J. Peter Rubin, MD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounded Warrior, Limb Shortening, Amputation
- What is being tested?
- Enhanced Fat Grafting and Standard fat graft
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2014to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Adipose Stromal Cell Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites: A Single Center Site, Prospective, Randomized, Pilot Outcomes Trial
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.
Read the detailed description
We hypothesize that autologous fat grafting can provide a minimally invasive therapy facilitated by enabling technology of specialized instrumentation to effectively mitigate pain syndromes at amputation sites, by introducing volume stable subcutaneous tissue over bony prominences and peripheral nerve trunks, thereby avoiding surgical revisions and preserving limb length.
We further hypothesize that enriching the fat graft with autologous adipose stromal cells utilizing the Tissue Gensis Cell Isolation System (CIS), a regenerative medicine approach, will lead to improved retention of the fat graft over time and result in a more favorable outcome.
Specific Aims:
- Treat painful amputation sites in 30 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. The primary outcome measures will be pain at the amputation site and improved ability to tolerate a prosthesis. Patients will be randomized to receive either standard fat grafting (15 patients)or cell enriched fat grafting (15 patients). Patients will be enrolled who have pain at an amputation site that limits function and/or interferes with the ability to use a prosthesis.
- Assess 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.
- Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures. This will include, among other tools, SF 36, the Beck inventory, and instruments designed for assessing limb function.
Study Design:
Single center site, prospective, randomized, pilot outcomes study with treatment performed at the University of Pittsburgh.
The primary outcome measurements will be: 1) fat graft retention at the amputation site; and 2) improved ability to tolerate a prosthetic device. This study will examine if fat grafting with cell enrichment using the Tissue Gensis Cell Isolation System, (CIS) will demonstrate increased fat retention and decreased pain compared to standard fat grafting alone.
Clinical Impact:
This study will significantly impact military trauma care by validating a minimally invasive cell based technique for alleviating pain at amputation sites and improving function with a prosthesis. Importantly, the goal will be reached without invasive surgery, increased risk, and a prolonged recovery. Given the high amputation rate in the current conflicts, this work is highly relevant to the care of the wounded warrior. A major goal of this study will be to transfer the techniques and knowledge gained to physicians throughout the Department of Defense healthcare system.
- Conditions
- Wounded Warrior, Limb Shortening, Amputation
- Being tested
- Enhanced Fat Grafting, Standard fat graft
- Keywords
- Fat Grafting, Pain at amputation site, prosthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Fat GraftingDevice
Also called Tissue Genesis Cell Isolation System™ (CIS)
The stromal vascular fraction (SVF) cell suspension (device output) will be processed using the Tissue Genesis Cell Isolation System™
The Standard graft material and the stromal vascular fraction cells will be mixed and subsequently injected into the amputated stump at a concentration of 2.0 - 3.0 x 10 6 stromal vascular cells/ml of injected fat graft to each site. The volume of each injected fat graft will depend on the volume requirements for each injured extremity.
To manually combine the standard fat graft material and the SVF suspension (device output), each of the syringes will be connected via luer to luer lock. The contents of the lipoaspirate syringe are transferred to the SVF syringe and the cell suspension will be injected slowly back and forth between the two (2) syringes. The final 1 mL SVF-fat graft syringe is now considered cell-enriched and ready for injection into the subject.
Standard fat graftProcedure or surgery
Aspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas
| Study group | Role | What they receive |
|---|---|---|
| Standard fat grafting | Active comparator | Once harvested the aspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas Receives: Procedure: Standard fat graft |
| Enhanced Fat Grafting | Experimental | Approximately 60 cc of lipoaspirate will be collected from the subject to be processed with the Tissue Genesis Cell Isolation System™ (CIS) to yield approximately 35cc of Stromal Vascular Fraction (SVF).Once harvested the aspirated fat will then be divided into two portions: one portion will be processed as standard graft material (standard/control graft) while the other portion will be used in a processing step that concentrates the adipose stromal cells.
The aspirated fat processed as standard graft material will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and allowed to decant before separating the fluid and oil layers from the fat tissue fractions, and transferred into 50 ml syringes. This graft preparation will be performed in the operating room. Receives: Device: Enhanced Fat Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Autologous Fat Transfer at Pain Modulation at Respective Amputation Sites
Assess the efficacy of minimally invasive autologous fat transfer at the amputation sites and the modulation of pain at the respective sites
Compare two minimally invasive techniques as an alternative to invasive operations, with the understanding that this therapy does not preclude more invasive procedures in the future. We further hypothesize that enriching the fat graft with autologous adipose stromal cells utilizing the Tissue Genesis Cell Isolation System (CIS), a regenerative medicine approach, will lead to improved retention of the fat graft over time and result in a more favorable outcome.
Subjects reported pain on a scale of 0-5 where 5 was the worst pain and 0 was no pain.
Measured: 2 years
Secondary outcomes (2)
Cell Yield
To assess biologic properties of the cells within the fat graft, we evaluated adipose stem cell viability by multiparameter flow cytometry.
Measured: day 0
Number of Participants With Clinically Significant Levels of Depression on the Patient Health Questionnaire-9 (PHQ-9)
Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures. This will evaluate using instruments designed for assessing depression including the Patient Health Questionnaire-9 (PHQ-9) which is a tool to screen, diagnose, monitor, and measure the severity of depression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start8 Apr 2014
- Primary completion18 Jul 2018
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wounded WarriorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- J. Peter Rubin, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, J. Peter Rubin, MD, University of Pittsburgh
- Investigators
- Joseph P Rubin, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076022
- Sponsor's protocol ID
- PRO12050147
- Acronym
- AMP30
- Status last verified
- Oct 2020
- First submitted
- 27 Feb 2014
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: It is the Principal Investigator's intention to make subject de-identified information available to secondary investigators after all research study testing has been completed. These associated subject information will not include subject identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Stromal Cell Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites: A Single Center Site, Prospective, Randomized, Pilot Outcomes Trial
- ClinicalTrials.gov ID
- NCT02076022
- Acronym / sponsor ID
- AMP30 / PRO12050147
- Conditions
- Wounded Warrior, Limb Shortening, Amputation
- Keywords
- Fat Grafting, Pain at amputation site, prosthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- J. Peter Rubin, MDUniversity, hospital or other
- Study start
- 8 Apr 2014 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We hypothesize that autologous fat grafting can provide a minimally invasive therapy facilitated by enabling technology of specialized instrumentation to effectively mitigate pain syndromes at amputation sites, by introducing volume stable subcutaneous tissue over bony prominences and peripheral nerve trunks, thereby avoiding surgical revisions and preserving limb length.
We further hypothesize that enriching the fat graft with autologous adipose stromal cells utilizing the Tissue Gensis Cell Isolation System (CIS), a regenerative medicine approach, will lead to improved retention of the fat graft over time and result in a more favorable outcome.
Specific Aims:
- Treat painful amputation sites in 30 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. The primary outcome measures will be pain at the amputation site and improved ability to tolerate a prosthesis. Patients will be randomized to receive either standard fat grafting (15 patients)or cell enriched fat grafting (15 patients). Patients will be enrolled who have pain at an amputation site that limits function and/or interferes with the ability to use a prosthesis.
- Assess 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.
- Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures. This will include, among other tools, SF 36, the Beck inventory, and instruments designed for assessing limb function.
Study Design:
Single center site, prospective, randomized, pilot outcomes study with treatment performed at the University of Pittsburgh.
The primary outcome measurements will be: 1) fat graft retention at the amputation site; and 2) improved ability to tolerate a prosthetic device. This study will examine if fat grafting with cell enrichment using the Tissue Gensis Cell Isolation System, (CIS) will demonstrate increased fat retention and decreased pain compared to standard fat grafting alone.
Clinical Impact:
This study will significantly impact military trauma care by validating a minimally invasive cell based technique for alleviating pain at amputation sites and improving function with a prosthesis. Importantly, the goal will be reached without invasive surgery, increased risk, and a prolonged recovery. Given the high amputation rate in the current conflicts, this work is highly relevant to the care of the wounded warrior. A major goal of this study will be to transfer the techniques and knowledge gained to physicians throughout the Department of Defense healthcare system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard fat grafting | Active comparator | Procedure: Standard fat graftOnce harvested the aspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas |
| Enhanced Fat Grafting | Experimental | Device: Enhanced Fat GraftingApproximately 60 cc of lipoaspirate will be collected from the subject to be processed with the Tissue Genesis Cell Isolation System™ (CIS) to yield approximately 35cc of Stromal Vascular Fraction (SVF).Once harvested the aspirated fat will then be divided into two portions: one portion will be processed as standard graft material (standard/control graft) while the other portion will be used in a processing step that concentrates the adipose stromal cells. The aspirated fat processed as standard graft material will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and allowed to decant before separating the fluid and oil layers from the fat tissue fractions, and transferred into 50 ml syringes. This graft preparation will be performed in the operating room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Fat GraftingAlso: Tissue Genesis Cell Isolation System™ (CIS)The stromal vascular fraction (SVF) cell suspension (device output) will be processed using the Tissue Genesis Cell Isolation System™ The Standard graft material and the stromal vascular fraction cells will be mixed and subsequently injected into the amputated stump at a concentration of 2.0 - 3.0 x 10 6 stromal vascular cells/ml of injected fat graft to each site. The volume of each injected fat graft will depend on the volume requirements for each injured extremity. To manually combine the standard fat graft material and the SVF suspension (device output), each of the syringes will be connected via luer to luer lock. The contents of the lipoaspirate syringe are transferred to the SVF syringe and the cell suspension will be injected slowly back and forth between the two (2) syringes. The final 1 mL SVF-fat graft syringe is now considered cell-enriched and ready for injection into the subject. | Device | Enhanced Fat Grafting |
| Standard fat graftAspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas | Procedure or surgery | Standard fat grafting |
Primary outcome
Efficacy of Autologous Fat Transfer at Pain Modulation at Respective Amputation Sites
Time frame: 2 years
Assess the efficacy of minimally invasive autologous fat transfer at the amputation sites and the modulation of pain at the respective sites Compare two minimally invasive techniques as an alternative to invasive operations, with the understanding that this therapy does not preclude more invasive procedures in the future. We further hypothesize that enriching the fat graft with autologous adipose stromal cells utilizing the Tissue Genesis Cell Isolation System (CIS), a regenerative medicine approach, will lead to improved retention of the fat graft over time and result in a more favorable outcome. Subjects reported pain on a scale of 0-5 where 5 was the worst pain and 0 was no pain.
2 secondary outcomes
Cell Yield
Time frame: day 0
Number of Participants With Clinically Significant Levels of Depression on the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Pittsburgh Department of Plastic SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. It is the Principal Investigator's intention to make subject de-identified information available to secondary investigators after all research study testing has been completed. These associated subject information will not include subject identifiers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph P Rubin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Fat Grafting and Standard fat graft in people with Wounded Warrior and Limb Shortening, run by J. Peter Rubin, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Autologous Fat Transfer at Pain Modulation at Respective Amputation Sites (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.