Completed

Autologous Fat Grafting for Pedal Fat Pad Atrophy

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What is being tested

Pedal Fat Grafting

+ Local anesthetic

+ Pedal Fat Grafting

ProcedureOther
Who is being recruted

Pathological Conditions, Signs and Symptoms

+ Pathological Conditions, Anatomical

+ Atrophy

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Pittsburgh
Last updated: February 14, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The etiology of plantar fat pad atrophy may be age-related, due abnormal foot mechanics, steroid use, or collagen vascular disease. Displacement or atrophy of the fat pad can lead to osseous prominences in the forefoot that may be seen with painful skin lesions. Disease states, such as diabetes, may have loss of soft tissue integrity. Fat pad atrophy, regardless of the etiology, may result in significant pain, epidermal lesions, or metatarsalgia. In sensate patients, the pain can lead to emotional and physical pain, leading to productivity and financial losses.1 It is well documented that plantar pressure is directly correlated with plantar tissue thickness, with the loss of plantar fat being a fundamental mechanism for pressure related foot disorders.2,3 Autologous fat grafting to areas of plantar fat pad atrophy may reduce plantar pressures, and thus serve as a treatment for metatarsalgia, corn and callus prevention, and possibly ulcer prevention in diabetics. Plastic surgeons, with significant skills in fat grafting, can make a significant contribution. Current treatment modalities for fat pad atrophy include silicone injections, fat injections, and other temporary fillers; however, no objective studies using autologous fat have been performed. Approximately 30 adults who experience pain from fat pad atrophy, will have the option to participate. Through a randomized, controlled, cross-over study, some patients will receive autologous fat grafting, while some will receive standard of care podiatric treatment, then cross-over to fat grafting treatment after a year. Through pedobarograph and ultrasound assessments, the focal pedal pressure and tissue thickness following treatment will be documented over two years. The investigators hypothesize that fat grafting for areas of increased pedal pressure will help decrease foot pressure during gait and increase soft tissue thickness on the foot pad, ultimately reducing pain. The investigators also hope to demonstrate that by using autologous fat with evidence-based fat transfer techniques, results may be durable. This pilot study will help build new collaborative efforts between Foot and Ankle Surgery, Podiatry and Plastic Surgery, combining expertise in foot biomechanics with reconstructive fat grafting.

Principal SponsorUniversity of Pittsburgh
Last updated: February 14, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalAtrophy

Criteria

4 inclusion criteria required to participate
6 months post any surgical intervention to the foot

Aged 18 years or older and able to provide informed consent

Patients with foot pain at the plantar surface of the foot near the head of the metacarpals

Willing and able to comply with follow up examinations, including ultrasounds and pedobarographic studies

11 exclusion criteria prevent from participating
Active infection anywhere in the body

Age less than 18 years

Diabetics: Type I and II

Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Screening visit followed by pedal fat grafting procedure with local anesthetic and visits at: 1 week Post op study visit 2 (1 month) Post op study visit 3 (2 month) Post op study visit 4 (6 month) Post op study visit 5 (12 month) Crossover to standard podiatry visits Study visit 6 (18 months) Study visit 7 (24 months)

Group II

Screening visit followed by: Study visit 1 (6months) Study Visit 2 (12 months) Crossover to Pathway A pedal fat grafting procedure and local anesthetic and visits at: 1 week Post op study visit 2 (1 month post procedure) Post op study visit 3 (2 month post procedure) Post op study visit 4 (6 month post procedure) Post op study visit 5 (12 month post procedure)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

UPMC Department of Plastic Surgery

Pittsburgh, United StatesOpen UPMC Department of Plastic Surgery in Google Maps
CompletedOne Study Center