Pedal Fat Pad AtrophyNCT02638532
Volumetric Analysis in Autologous Fat Grafting to the Foot
A study testing Foot Fat Pad Grafting in people with Pedal Fat Pad Atrophy, run by University of Pittsburgh at 1 site in United States.
Trial summary
The specific aim of this outcomes study is to assess if the volume of fat that is injected into the foot is retained at 6 months, to determine the retention over time, and assess the quality of the bone before and after treatment. We will also correlate adipose stem cell characteristics to the fat retention over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pedal Fat Pad Atrophy
- What is being tested?
- Foot Fat Pad Grafting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, basically healthy and able to provide informed consent.
- Patients with forefoot or rearfoot pain overlying the bone with fat pad atrophy.
- At least 6 months post any surgical intervention to the foot.
- Willing and able to comply with follow up examinations, including ultrasounds, MRI, and pedobarographic studies.
- Diabetics: Type I and II with a HgA1C < or = 7.
- Have tried and failed at least one form of conservative management (i.e. orthotics, padding, etc.).
Who cannot join
- Age less than 18 years.
- Inability to provide informed consent
- Feet with open ulcerations or osteomyelitis.
- Diabetics: Type I and II iwth a HgAIC > 7.
- 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.
- Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
- Pregnancy.
- Subjects with a diagnosis of Schizophrenia or Bipolar Disorder due to the inability to comply with study instructions, due in part to comorbidities (Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion).
- Tobacco use: Last use within 1 year per patient report.
- Patients with heart pacemakers, aneurysm clips, ear implants, IUD, shrapnel or metallic fragments in or on the body or eyes, neuro-stimulators, or other metal devices.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Department of Plastic Surgery
Pittsburgh, Pennsylvania, 15213
About this study
The specific aim of this outcomes study is to assess if the volume of fat that is injected into the foot is retained at 6 months, to determine the retention over time, and assess the quality of the bone before and after treatment. We will also correlate adipose stem cell characteristics to the fat retention over time.
Read the detailed description
The study goal is to utilize MRI to further understand changes that are occurring in the foot when autologous fat is used to treat plantar fat pad atrophy of the foot. The etiology of fat pad atrophy may be age-related, due to abnormal foot mechanics, obesity, steroid use, or collagen vascular disease. Displacement or atrophy of the fat pad can lead to osseous prominences in the foot that may be seen with painful skin lesions. Disease states, such as diabetes, may have loss of soft tissue integrity. Fat pad atrophy may result in significant pain or compensatory gait leading to callous formation or ulceration. In sensate patients, the pain can lead to emotional and physical pain, leading to productivity and financial losses.
Fat grafting to the feet is as a cosmetic surgery option. Although fat grafting is used often in standard care plastic surgery, for cosmetic reasons, it is considered part of the research in this trial. What happens to the fat after injection has not been well studied. Approximately 50 adults who experience pain from fat pad atrophy, either of the fore foot or heel will have fat pad grafting. The study will utilize MRI before and at 6 months post-procedure to assess changes in the quality of the bone of the foot as well as the 3D morphology of the fat. Specifically, the investigators want to know how the fat redistributes around the bone. In addition, the Adipose Stem Cell Biology Laboratory will assess the stem cell characteristics of the fat used for autotransplantation. This study will help build new collaborative efforts between Foot and Ankle Specialists, Stem Cell Biologists, and Plastic Surgeons, combining expertise in foot biomechanics with reconstructive fat grafting.
- Conditions
- Pedal Fat Pad Atrophy
- Being tested
- Foot Fat Pad Grafting
- Keywords
- Fat Pad, Fat Pad Atrophy, Foot, Feet, Heel, Forefoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Fat Pad GraftingProcedure or surgery
Fat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula. 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 loaded into 1cc syringes and injected into the plantar fat pad using specialized injection cannulas.
| Study group | Role | What they receive |
|---|---|---|
| Foot Fat Pad Grafting | Other | All subject who enter into the study will undergo the fat pad grafting procedure to either the Heel or Forefoot based on the discretion of the PI, Co-investigator and the study subject. Receives: Procedure: Foot Fat Pad Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilize MRI to determine the 3D volumetric changes in the soft tissue of the foot after fat grafting and the changes in bone quality after fat grafting.
Comparative analysis of the scans will be done to note fat re-distribution and bone quality pre and post procedure.
Measured: Baseline and 6 months post-procedure
Secondary outcomes (5)
Ultrasound to measure tissue thickness of foot
Tissue thickness will be measured in MM. They will utilized to ascertain changes from pre procedure to 6 months post-procedure.
Measured: Baseline, 1 month, 2 months and 6 months post-procedure
Pedobarograph to measure foot pressure and force while standing and walking
Foot pressure is measured in Kg/cm2 or psi. The pedobarograph provides imaging to show areas of distribution of pressure to the foot when subject stands and walks.
Measured: Baseline, 1 month, 2 months and 6 months post-procedure
Adipose stem cell counts
excess fat from the procedure will be sent for stem cell analysis and used to corelate to retention of fat over time.
Measured: Fat grafting procedure, 6 months
Manchester Foot Disability Index for pain
Pain is assessed through the completion of a questionnaire that is scored.
Measured: baseline, 1 month, 2 month and 6 month post procedure.
Foot and Ankle Ability Measure for physical activity
Activity level is assessed by subject rating different activities on the difficulty to complete the activities. The questionnaire is then scored.
Measured: baseline, 1 mont, 2 month, and 6 month post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pedal Fat Pad AtrophyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey A. Gusenoff, MD, University of Pittsburgh
- Investigators
- Jeffery A Gusenoff, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638532
- Sponsor's protocol ID
- PRO15090106
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2015
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Analysis in Autologous Fat Grafting to the Foot
- ClinicalTrials.gov ID
- NCT02638532
- Acronym / sponsor ID
- PRO15090106
- Conditions
- Pedal Fat Pad Atrophy
- Keywords
- Fat Pad, Fat Pad Atrophy, Foot, Feet, Heel, Forefoot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this outcomes study is to assess if the volume of fat that is injected into the foot is retained at 6 months, to determine the retention over time, and assess the quality of the bone before and after treatment. We will also correlate adipose stem cell characteristics to the fat retention over time.
Detailed description
The study goal is to utilize MRI to further understand changes that are occurring in the foot when autologous fat is used to treat plantar fat pad atrophy of the foot. The etiology of fat pad atrophy may be age-related, due to abnormal foot mechanics, obesity, steroid use, or collagen vascular disease. Displacement or atrophy of the fat pad can lead to osseous prominences in the foot that may be seen with painful skin lesions. Disease states, such as diabetes, may have loss of soft tissue integrity. Fat pad atrophy may result in significant pain or compensatory gait leading to callous formation or ulceration. In sensate patients, the pain can lead to emotional and physical pain, leading to productivity and financial losses.
Fat grafting to the feet is as a cosmetic surgery option. Although fat grafting is used often in standard care plastic surgery, for cosmetic reasons, it is considered part of the research in this trial. What happens to the fat after injection has not been well studied. Approximately 50 adults who experience pain from fat pad atrophy, either of the fore foot or heel will have fat pad grafting. The study will utilize MRI before and at 6 months post-procedure to assess changes in the quality of the bone of the foot as well as the 3D morphology of the fat. Specifically, the investigators want to know how the fat redistributes around the bone. In addition, the Adipose Stem Cell Biology Laboratory will assess the stem cell characteristics of the fat used for autotransplantation. This study will help build new collaborative efforts between Foot and Ankle Specialists, Stem Cell Biologists, and Plastic Surgeons, combining expertise in foot biomechanics with reconstructive fat grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foot Fat Pad Grafting | Other | Procedure: Foot Fat Pad GraftingAll subject who enter into the study will undergo the fat pad grafting procedure to either the Heel or Forefoot based on the discretion of the PI, Co-investigator and the study subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older, basically healthy and able to provide informed consent.
- Patients with forefoot or rearfoot pain overlying the bone with fat pad atrophy.
- At least 6 months post any surgical intervention to the foot.
- Willing and able to comply with follow up examinations, including ultrasounds, MRI, and pedobarographic studies.
- Diabetics: Type I and II with a HgA1C < or = 7.
Key exclusion criteria (12 listed)
- Age less than 18 years.
- Inability to provide informed consent
- Feet with open ulcerations or osteomyelitis.
- Diabetics: Type I and II iwth a HgAIC > 7.
- 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 |
|---|---|---|
| Foot Fat Pad GraftingFat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula. 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 loaded into 1cc syringes and injected into the plantar fat pad using specialized injection cannulas. | Procedure or surgery | Foot Fat Pad Grafting |
Primary outcome
Utilize MRI to determine the 3D volumetric changes in the soft tissue of the foot after fat grafting and the changes in bone quality after fat grafting.
Time frame: Baseline and 6 months post-procedure
Comparative analysis of the scans will be done to note fat re-distribution and bone quality pre and post procedure.
5 secondary outcomes
Ultrasound to measure tissue thickness of foot
Time frame: Baseline, 1 month, 2 months and 6 months post-procedure
Pedobarograph to measure foot pressure and force while standing and walking
Time frame: Baseline, 1 month, 2 months and 6 months post-procedure
Adipose stem cell counts
Time frame: Fat grafting procedure, 6 months
Manchester Foot Disability Index for pain
Time frame: baseline, 1 month, 2 month and 6 month post procedure.
Foot and Ankle Ability Measure for physical activity
Time frame: baseline, 1 mont, 2 month, and 6 month post procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
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.
Jeffery A Gusenoff, 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 Foot Fat Pad Grafting in people with Pedal Fat Pad Atrophy, run by University of Pittsburgh 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 6 inclusion and 12 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 6 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Utilize MRI to determine the 3D volumetric changes in the soft tissue of the foot after fat grafting and the changes in bone quality after fat grafting. (time frame: Baseline and 6 months post-procedure). 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 6 Dec 2019.