Fat Pad AtrophyNCT02679651
Diagnostic Modeling for Pedal Fat Pad Atrophy
An observational study of Fat Pad Atrophy and Pain, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators hypothesize that there is a difference in plantar tissue thickness, plantar pressure, and pain score in patients diagnosed with plantar fat pad atrophy compared to healthy, foot-type matched controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fat Pad Atrophy, Pain
- What is being tested?
- Ultrasound of the foot, Pedobarograph Measurements and Manchester Foot Pain and Disability Index
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 healthy, age matched adults with normal foot fat pads to compare to 30 patients in the fat pad atrophy group from our other IRB approved clinical trials.
Who may be able to join
- Aged 18 years or older
- Patients without foot pain at the plantar surface of the foot near the head of the metatarsals
- 6 months post any surgical intervention to the foot
- Subjects must be determined by the PI or a Co-Investigator to not suffer from pedal pad atrophy
Who cannot join
- Age less than 18 years
- Inability to provide informed consent
- Feet with open ulcerations or osteomyelitis
- Diabetics: Type I and II
- Active infection anywhere in the body
- Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
- Pregnancy
- Tobacco use: Last use within 1 year per patient report
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Department of Plastic Surgury
Pittsburgh, Pennsylvania, 15213
About this study
The investigators hypothesize that there is a difference in plantar tissue thickness, plantar pressure, and pain score in patients diagnosed with plantar fat pad atrophy compared to healthy, foot-type matched controls. Results will be measured objectively using ultrasound for tissue thickness, optical pedobarograph for plantar pressure, and Manchester foot pain and disability index (MFPDI) for pain score. Furthermore, investigators predict that these results will help establish criteria for fad pad atrophy diagnosis in the clinic as well as determine which patients would receive greatest benefit from fat grafting to the foot.
Read the detailed description
Human feet must bear the entire weight of the body. Feet have fat pads on their plantar surface that act as shock absorbers between the skin and bone. However, repetitive mechanical stress throughout a person's lifetime leads to gradual atrophy of these fat pads. In addition to this age-related degeneration, fat pad atrophy can be caused by other mechanisms such as abnormal foot mechanics, steroid use, and collagen vascular disease. Regardless of the cause, many patients with plantar fat pad atrophy experience considerable pain and loss of function.
Previous studies have negatively correlated plantar soft tissue thickness with plantar pressure, with the loss of plantar fat being a fundamental mechanism associated with pressure-related foot disorders. Increased pressure from fat pad atrophy is commonly managed with padded socks, insoles, and shoe modification. However, these extrinsic strategies are totally dependent on patient compliance, and devices must be replaced as soon as they begin to break down. Another treatment option includes silicone injections into the plantar aspect of the foot. In one study, patients receiving silicone treatment experienced increased plantar tissue thickness and decreased plantar pressure, but these cushioning properties decreased over time and the need for additional booster injections was ultimately suggested. Furthermore, silicone has been known to migrate away from the injection site and has been found in the inguinal lymph nodes of patients.
A different strategy that is gaining momentum is autologous fat grafting to the foot. Taking a patient's own tissue, often from the abdomen or thigh, and transplanting it to areas of plantar fat pad atrophy may reduce pressure in a more natural and permanent manner. Only one study to date has been published on autologous fat grafting to the foot, but the patients were receiving concurrent surgical procedures with their fat grafting and the results were reported subjectively by the patients.
In this study, the investigators hypothesize that there is a difference in plantar tissue thickness, plantar pressure, and pain score in patients diagnosed with plantar fat pad atrophy compared to healthy, foot-type matched controls. Results will be measured objectively using ultrasound for tissue thickness, optical pedobarograph for plantar pressure, and Manchester foot pain and disability index (MFPDI) for pain score. Furthermore, the investigators predict that these results will help establish criteria for fad pad atrophy diagnosis in the clinic as well as determine which patients would receive greatest benefit from fat grafting to the foot.
- Conditions
- Fat Pad Atrophy, Pain
- Being tested
- Ultrasound of the foot, Pedobarograph Measurements, Manchester Foot Pain and Disability Index
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the footOther
An ultrasound will be used to determine the thickness of the fat pad
Pedobarograph MeasurementsOther
This non-invasive device measures the force and pressure of the foot while standing and walking.
Manchester Foot Pain and Disability IndexOther
This is a patient completed questionnaire that assesses level of function from the past month specific to foot pain.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy Adults without foot pain Receives: Other: Ultrasound of the foot; Other: Pedobarograph Measurements; Other: Manchester Foot Pain and Disability Index | |
| DIsease group | Adults diagnosed with fat pat atrophy and report symptoms of foot pain and have participated in clinical trial to treat fat pad atrophy. Receives: Other: Ultrasound of the foot; Other: Pedobarograph Measurements; Other: Manchester Foot Pain and Disability Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar fat pad thickness
Fat pad thickness measured via ultrasound
Measured: Screening
Plantar foot pressure
Assessed by optical pedobarograph
Measured: Screening
Pain score
Assessed by patient completed Manchester foot pain and disability index
Measured: Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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
- Jeffrey A Gusenoff, MD, Principal investigator, University of Pittsburgh Department of Plastic SurgeryConnor Davenport, BS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679651
- Sponsor's protocol ID
- PRO15060610
- Status last verified
- Jul 2020
- First submitted
- 6 Feb 2016
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bowling FL, Metcalfe SA, Wu S, Boulton AJ, Armstrong DG. Liquid silicone to mitigate plantar pedal pressure: a literature review. J Diabetes Sci Technol. 2010 Jul 1;4(4):846-52. doi: 10.1177/193229681000400412.
PubMed 20663447Abouaesha F, van Schie CH, Griffths GD, Young RJ, Boulton AJ. Plantar tissue thickness is related to peak plantar pressure in the high-risk diabetic foot. Diabetes Care. 2001 Jul;24(7):1270-4. doi: 10.2337/diacare.24.7.1270.
PubMed 11423514Abouaesha F, van Schie CH, Armstrong DG, Boulton AJ. Plantar soft-tissue thickness predicts high peak plantar pressure in the diabetic foot. J Am Podiatr Med Assoc. 2004 Jan-Feb;94(1):39-42. doi: 10.7547/87507315-94-1-39.
PubMed 14729989van Schie CH, Whalley A, Vileikyte L, Wignall T, Hollis S, Boulton AJ. Efficacy of injected liquid silicone in the diabetic foot to reduce risk factors for ulceration: a randomized double-blind placebo-controlled trial. Diabetes Care. 2000 May;23(5):634-8. doi: 10.2337/diacare.23.5.634.
PubMed 108344225. Van Schie CHM, Whalley A, Vileikyte L, Boulton AJM (2002) Efficacy of injected liquid silicone is related to peak plantar foot pressures in the neuropathic diabetic foot. Wounds 14:26-30
Chairman EL. Restoration of the plantar fat pad with autolipotransplantation. J Foot Ankle Surg. 1994 Jul-Aug;33(4):373-9.
PubMed 7951190Menz HB, Tiedemann A, Kwan MM, Plumb K, Lord SR. Foot pain in community-dwelling older people: an evaluation of the Manchester Foot Pain and Disability Index. Rheumatology (Oxford). 2006 Jul;45(7):863-7. doi: 10.1093/rheumatology/kel002. Epub 2006 Jan 31.
PubMed 16449369Waldecker U. Plantar fat pad atrophy: a cause of metatarsalgia? J Foot Ankle Surg. 2001 Jan-Feb;40(1):21-7. doi: 10.1016/s1067-2516(01)80037-5.
PubMed 11202764
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Modeling for Pedal Fat Pad Atrophy
- ClinicalTrials.gov ID
- NCT02679651
- Acronym / sponsor ID
- PRO15060610
- Conditions
- Fat Pad Atrophy, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 10 Feb 2016 (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 investigators hypothesize that there is a difference in plantar tissue thickness, plantar pressure, and pain score in patients diagnosed with plantar fat pad atrophy compared to healthy, foot-type matched controls. Results will be measured objectively using ultrasound for tissue thickness, optical pedobarograph for plantar pressure, and Manchester foot pain and disability index (MFPDI) for pain score. Furthermore, investigators predict that these results will help establish criteria for fad pad atrophy diagnosis in the clinic as well as determine which patients would receive greatest benefit from fat grafting to the foot.
Detailed description
Human feet must bear the entire weight of the body. Feet have fat pads on their plantar surface that act as shock absorbers between the skin and bone. However, repetitive mechanical stress throughout a person's lifetime leads to gradual atrophy of these fat pads. In addition to this age-related degeneration, fat pad atrophy can be caused by other mechanisms such as abnormal foot mechanics, steroid use, and collagen vascular disease. Regardless of the cause, many patients with plantar fat pad atrophy experience considerable pain and loss of function.
Previous studies have negatively correlated plantar soft tissue thickness with plantar pressure, with the loss of plantar fat being a fundamental mechanism associated with pressure-related foot disorders. Increased pressure from fat pad atrophy is commonly managed with padded socks, insoles, and shoe modification. However, these extrinsic strategies are totally dependent on patient compliance, and devices must be replaced as soon as they begin to break down. Another treatment option includes silicone injections into the plantar aspect of the foot. In one study, patients receiving silicone treatment experienced increased plantar tissue thickness and decreased plantar pressure, but these cushioning properties decreased over time and the need for additional booster injections was ultimately suggested. Furthermore, silicone has been known to migrate away from the injection site and has been found in the inguinal lymph nodes of patients.
A different strategy that is gaining momentum is autologous fat grafting to the foot. Taking a patient's own tissue, often from the abdomen or thigh, and transplanting it to areas of plantar fat pad atrophy may reduce pressure in a more natural and permanent manner. Only one study to date has been published on autologous fat grafting to the foot, but the patients were receiving concurrent surgical procedures with their fat grafting and the results were reported subjectively by the patients.
In this study, the investigators hypothesize that there is a difference in plantar tissue thickness, plantar pressure, and pain score in patients diagnosed with plantar fat pad atrophy compared to healthy, foot-type matched controls. Results will be measured objectively using ultrasound for tissue thickness, optical pedobarograph for plantar pressure, and Manchester foot pain and disability index (MFPDI) for pain score. Furthermore, the investigators predict that these results will help establish criteria for fad pad atrophy diagnosis in the clinic as well as determine which patients would receive greatest benefit from fat grafting to the foot.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Ultrasound of the foot, Other: Pedobarograph Measurements, Other: Manchester Foot Pain and Disability IndexHealthy Adults without foot pain |
| DIsease group | – | Other: Ultrasound of the foot, Other: Pedobarograph Measurements, Other: Manchester Foot Pain and Disability IndexAdults diagnosed with fat pat atrophy and report symptoms of foot pain and have participated in clinical trial to treat fat pad atrophy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 healthy, age matched adults with normal foot fat pads to compare to 30 patients in the fat pad atrophy group from our other IRB approved clinical trials.
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Patients without foot pain at the plantar surface of the foot near the head of the metatarsals
- 6 months post any surgical intervention to the foot
- Subjects must be determined by the PI or a Co-Investigator to not suffer from pedal pad atrophy
Key exclusion criteria (8 listed)
- Age less than 18 years
- Inability to provide informed consent
- Feet with open ulcerations or osteomyelitis
- Diabetics: Type I and II
- 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 |
|---|---|---|
| Ultrasound of the footAn ultrasound will be used to determine the thickness of the fat pad | Other | Control group, DIsease group |
| Pedobarograph MeasurementsThis non-invasive device measures the force and pressure of the foot while standing and walking. | Other | Control group, DIsease group |
| Manchester Foot Pain and Disability IndexThis is a patient completed questionnaire that assesses level of function from the past month specific to foot pain. | Other | Control group, DIsease group |
Primary outcome
Plantar fat pad thickness
Time frame: Screening
Fat pad thickness measured via ultrasound
Plantar foot pressure
Time frame: Screening
Assessed by optical pedobarograph
Pain score
Time frame: Screening
Assessed by patient completed Manchester foot pain and disability index
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 14 Jul 2020.
- Background: PubMed 20663447Bowling FL, Metcalfe SA, Wu S, Boulton AJ, Armstrong DG. Liquid silicone to mitigate plantar pedal pressure: a literature review. J Diabetes Sci Technol. 2010 Jul 1;4(4):846-52. doi: 10.1177/193229681000400412.
- Background: PubMed 11423514Abouaesha F, van Schie CH, Griffths GD, Young RJ, Boulton AJ. Plantar tissue thickness is related to peak plantar pressure in the high-risk diabetic foot. Diabetes Care. 2001 Jul;24(7):1270-4. doi: 10.2337/diacare.24.7.1270.
- Background: PubMed 14729989Abouaesha F, van Schie CH, Armstrong DG, Boulton AJ. Plantar soft-tissue thickness predicts high peak plantar pressure in the diabetic foot. J Am Podiatr Med Assoc. 2004 Jan-Feb;94(1):39-42. doi: 10.7547/87507315-94-1-39.
- Background: PubMed 10834422van Schie CH, Whalley A, Vileikyte L, Wignall T, Hollis S, Boulton AJ. Efficacy of injected liquid silicone in the diabetic foot to reduce risk factors for ulceration: a randomized double-blind placebo-controlled trial. Diabetes Care. 2000 May;23(5):634-8. doi: 10.2337/diacare.23.5.634.
- Background5. Van Schie CHM, Whalley A, Vileikyte L, Boulton AJM (2002) Efficacy of injected liquid silicone is related to peak plantar foot pressures in the neuropathic diabetic foot. Wounds 14:26-30
- Background: PubMed 7951190Chairman EL. Restoration of the plantar fat pad with autolipotransplantation. J Foot Ankle Surg. 1994 Jul-Aug;33(4):373-9.
- Background: PubMed 16449369Menz HB, Tiedemann A, Kwan MM, Plumb K, Lord SR. Foot pain in community-dwelling older people: an evaluation of the Manchester Foot Pain and Disability Index. Rheumatology (Oxford). 2006 Jul;45(7):863-7. doi: 10.1093/rheumatology/kel002. Epub 2006 Jan 31.
- Background: PubMed 11202764Waldecker U. Plantar fat pad atrophy: a cause of metatarsalgia? J Foot Ankle Surg. 2001 Jan-Feb;40(1):21-7. doi: 10.1016/s1067-2516(01)80037-5.
- Individual participant dataSharing planned: No
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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.
Jeffrey A Gusenoff, MD principal investigator
University of Pittsburgh Department of Plastic Surgery
Connor Davenport, BS 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?
An observational study of Fat Pad Atrophy and Pain, 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 4 inclusion and 8 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 14 Jul 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?
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?
Plantar fat pad thickness (time frame: Screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679651, which also lists 8 linked publications.
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 14 Jul 2020.