What side effects are associated with this type of intervention?

Common treatments for foot ulcers, particularly those involving autologous tissue grafts like the injection of microsized adipose tissue, can have several side effects. These may include infection at the injection site, prolonged edema, contour irregularities, and necrosis or calcification of the injected fat. Additionally, there is a risk of fat emboli, which can lead to serious complications such as stroke or vision loss. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic foot ulcers, including advanced wound care products, growth factors, and skin substitutes. One notable approval is for the use of autologous platelet-rich plasma (PRP) injections, which promote wound healing by utilizing the patient's own blood components. While specific FDA approvals for the injection of autologous microsized adipose tissue are not detailed, the concept is similar to PRP in that it uses the patient's own biological materials to enhance healing. This approach aims to leverage the regenerative properties of adipose-derived cells to improve wound healing outcomes.

What other types of research exist?

Promising alternatives to the SyntrFuge™ system for treating foot ulcers include: 1) Genetically modified autologous cultured skin grafts, which have shown stable and complete epidermal regeneration in patients with severe skin conditions. 2) Beremagene geperpavec (B-VEC), a topical gene therapy that delivers a functional version of the COL7A1 gene to restore collagen production and promote wound healing. Both therapies have demonstrated significant efficacy in clinical trials and could be considered for foot ulcer treatment in 2024.

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Device

Adipose Tissue Treatment for Diabetic Foot Ulcers

N/A

Waitlist Available

Research Sponsored by Syntr Health Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects who have Diabetic Foot Ulcer located at the plantar or dorsal aspect of the foot or the heel with a surface area of 1.0cm2 - 25cm2

Subjects aged 18 - 85, inclusive

Must not have

Subjects unable to give informed, written consent

Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if injecting processed fat from a patient's own body can help heal foot wounds in diabetic patients faster than usual care.

Who is the study for?

This trial is for diabetic patients aged 18-85 with foot ulcers present for over four weeks, sized between 1.0cm2 and 25cm2. Participants must have an HbA1c level ≤12% and have offloaded the ulcer for at least two weeks. Excluded are those who've had certain recent treatments, corticosteroid therapy above a low threshold, cancer treatments within five years, active infections or osteomyelitis in the ulcer, pregnant or breastfeeding women, and individuals with HIV or Hep C.

What is being tested?

The study compares the healing effect of injecting microsized adipose tissue processed by SyntrFuge™ System into diabetic foot ulcers versus standard care alone. Patients will be randomly assigned to either receive this new treatment or continue with their usual wound care without it.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain, swelling or infection; however specific side effects related to SyntrFuge™ System aren't detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a diabetic foot ulcer between 1.0cm2 and 25cm2 in size.

Select...

I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand or sign the consent form.

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I have or had cancer treatment or tumors in the last 5 years.

Select...

I have an active bone infection in my ulcer.

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I am unable to make my own medical decisions.

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I have been diagnosed with HIV or Hepatitis C.

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I have an active infection with symptoms like redness, swelling, or pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: SyntrFuge SystemExperimental Treatment1 Intervention

Adipose tissue microsized via the SyntrFuge System

Group II: Standard of CareExperimental Treatment1 Intervention

Offloading

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SyntrFuge System

2021

N/A

~20

Standard of Care

2017

Completed Phase 4

~4420

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The treatment of foot ulcers using autologous microsized adipose tissue, such as that processed with the SyntrFuge™ system, leverages the regenerative properties of the patient's own fat. This approach involves injecting processed adipose tissue into the ulcer site, which provides a rich source of stem cells, growth factors, and extracellular matrix components. These elements work together to promote tissue repair, enhance wound healing, and reduce inflammation. For foot ulcer patients, this method is particularly beneficial as it can accelerate healing, decrease the risk of infection, and improve overall outcomes by utilizing the body's natural healing mechanisms.

Chronic prosthesis-related residual limb ulcer treated with autologous micro-fragmented adipose tissue.