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NCT01796808 · ClinicalTrials.gov registry record · NA

Fat Grafting for Pedal Fat Pad Atrophy

A NA study, sponsored by University of Pittsburgh.

Completed
Registry status
NA
Development phase
31
Enrollment target

NCT01796808: Completed NA study, sponsored by University of Pittsburgh.

NCT01796808 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01796808, a NA study, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
NA
Development phase
31 participants
Enrollment target

Study Summary

It is believed that the average person with an eighty year old life span will walk the distance of the world twice in their lifetime. The foot is comprised of a specialized fat pad to provide shock absorption and protection against breakdown. With all the walking humans do however, foot fat pad breakdown is inevitable. Trauma to the foot is compounded in the diabetic patients due to many reasons: loss of protective sensation secondary to neuropathy, reduced skin hydration, decreased soft tissue elasticity, elevated blood sugars and increased body weight to name a few. Increased foot pressure and decreased fat pad protection are the main contributing factors to callus formation, foot pain and ulcer formation. Fat grafting is a cosmetic and reconstructive procedure that is used sometimes to help improve one's soft tissue thickness, shape and integrity. Autologous fat transplantation is a procedure using a patient's own fat that is taken by a small liposuction tube, from areas with a substantial amount of fat ( i.e. abdomen or thighs) and then transferred into the fat atrophied (decreased or worn out) area (in this case, the foot). The investigators are performing this research in an effort to decrease foot pressure during activity and to increase the soft tissue thickness of the sole of the foot during one's lifetime. Ultimately this could help reduce foot pain, callus formation and even ulcer formation. The goal of this research is to see whether fat grafting will help decrease the prevalence of the aforementioned foot complications. The investigators hope that by using one's own fat tissue, he or she may have a longer duration of relief than by using other methods. This is a randomized, cross-over designed study. Randomized means that patients will be enrolled by chance (like the flip of a coin) to one of two groups for the first part of the study. Cross-over means that, after the first part of the study or at one year, patients will move into the opposite group.

Primary Outcome

Pressure will be measured on the pedobarograph in kg/cm2 or psi. Tissue thickness will be measured by ultrasound as mm. These measures will be performed before and after treatment with fat grafting to assess changes over time.

Interventions

  • PROCEDURE Pedal Fat Grafting
  • OTHER Local anesthetic

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2013-03
Est. Completion 2017-04
Phase NA
University of Pittsburgh

1,238 total trials

What the finished NCT01796808 record still lists

NCT01796808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Pedal Fat Grafting is the first listed.

NCT01796808 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01796808 about?

NCT01796808 is a clinical study titled "Fat Grafting for Pedal Fat Pad Atrophy". It is believed that the average person with an eighty year old life span will walk the distance of the world twice in their lifetime. The foot is comprised of a specialized fat pad to provide shock absorption and protection against breakdown. With all the walking humans do however, foot fat pad brea...

What is the current status of trial NCT01796808?

This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2013-03. Estimated completion is 2017-04.

What interventions are being tested in trial NCT01796808?

The interventions under investigation include: Pedal Fat Grafting (PROCEDURE), Local anesthetic (OTHER).

Who is sponsoring clinical trial NCT01796808?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01796808's enrollment target sits among peer trials

31 1592nd of 2000 higher than 408 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01796808, the US trial registry maintained by the National Library of Medicine. NCT01796808 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.