Fat Grafting for Pedal Fat Pad Atrophy in Diabetics

NCT02074683 | Completed DMC

• 1 other identifier: PRO13080186
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.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. We hypothesize that fat grafting for areas of increased pedal pressure in well-controlled diabetics will help decrease foot pressure during gait and increase soft tissue thickness on the foot pad, ultimately reducing pain. We 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.

Conditions

Pedal Pad Atrophy; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Durability of Relief and reduction of foot pressure

  The specific aim of this outcomes study is to assess if fat grafting to areas of increased pedal pressure in well-controlled diabetic patients with metatarsalgia will reduce foot pressure during gait, increase the soft tissue thickness of the foot pad and ultimately reduce pain. Data from this study will help determine the durability of relief from this treatment and open the doors to additional studies using other modalities.

  24 months

Secondary Outcomes (3)

• Measurement of pedal pressure and plantar tissue thickness

  24 months

• Measurement of durability of fat grafting vs silicone or other fillers

  24 Months

• Assessment of pain and skin lesions

  24 months

Study Arms (2)

YEAR A PATHWAY

ACTIVE COMPARATOR

Operative Procedure will occur after screening visit. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. In brief, 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. Follow-up visits: 1. Post op Visit 1 (2 weeks +/- 5 days) 2. Post op study visit 2 (1 month) 3. Post op study visit 3 (2 month) 4. Post op study visit 4 (6 month) 5. Post op study visit 5 (12 month) CROSSOVER to YEAR B PathWay 6. Post op study visit 6 (18 months) 7. Post op study visit 7 (24 months)

Procedure: Year A Pathway

Year B Pathway

ACTIVE COMPARATOR

Observational visits at 6 and 12 months with fat grafting procedures during year 2. 1. Study visit 1 (month 6) 2. Study Visit 2 (month 12) 1. Collection of subject's medication profile, vital signs (Temp, HR, Resp, BP), and weight to calculate BMI, 2. Limited physical exam with a foot exam completed by the PI and /or the Coinvestigator 3. Adverse Event Reporting 4. Ultrasound 5. Pedobarograph 6. 2D Photographs 7. Foot Pain Assessment Questionnaire 8. Medical chart review including review of records from SOC podiatrists 3. Operative Visit Followed by Post op study visits 2-5 as described in Year A Pathway

Procedure: Year B Pathway

Interventions

Year A Pathway PROCEDURE

Fat Grafting Operative Procedure followed by Standard of Care Follow-up.

Also known as: Fat Grafting Operative Porcedure

YEAR A PATHWAY

Year B Pathway PROCEDURE

Standard of Care Followed by Fat Grafting Operative Procedure

Year B Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• months post any surgical intervention to the foot
• Willing and able to comply with follow up examinations, including ultrasounds and pedobarographic studies
• Diabetics: Type I and II with a HgA1C \< or = 7

You may not qualify if:

• 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
• 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 (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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Department of Plastic Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jeffrey Gusenoff, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: November 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

US (1)