Volumetric Analysis in Autologous Fat Grafting to the Foot (NCT02638532) | Clinical Trial Compass
CompletedNot Applicable
Volumetric Analysis in Autologous Fat Grafting to the Foot
United States17 participantsStarted 2016-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.).
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.