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Adipose Tissue Treatment for Diabetic Foot Ulcers
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will test whether injecting micro-sized fat cells from patients' own bodies can help heal diabetic foot ulcers faster.
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.Check my eligibility
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.See study design
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 belowSelect...
I have a diabetic foot ulcer between 1.0cm2 and 25cm2 in size.
Select...
I am between 18 and 85 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of subjects with study wound deemed closed at 12 weeks
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
Standard of Care
2017
Completed Phase 4
~4420
Find a Location
Who is running the clinical trial?
Syntr Health Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
226 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had treatments like wound therapy, growth factors, radiation, hyperbaric oxygen, or bioengineered tissue in the last 30 days.I have a diabetic foot ulcer between 1.0cm2 and 25cm2 in size.People with diabetes included in the study have HbA1c levels less than or equal to 12%.My ulcer has been present for more than four weeks.I am on a low dose of corticosteroids, 5mg/dl or less.I am unable to understand or sign the consent form.I have or had cancer treatment or tumors in the last 5 years.I have an active bone infection in my ulcer.I am between 18 and 85 years old.I am unable to make my own medical decisions.I have been diagnosed with HIV or Hepatitis C.I have an active infection with symptoms like redness, swelling, or pain.My ulcer has not been under pressure for at least 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: SyntrFuge System
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals of a junior age bracket being accepted for the clinical trial?
"Admissible participants for this research must be of age and under 85."
Answered by AI
Could I potentially become a subject of this research project?
"For this clinical trial, 60 participants aged 18 to 85 with diabetic foot ulcers (DFUs) must meet additional criteria. The index ulcer should be 1-25 cm2 in area and have been present for more than four weeks. Additionally, these patients' HbA1c levels should not exceed 12%, and the target ulcer must have been offloaded for 14 days or longer."
Answered by AI
What is the approximate number of participants being recruited for this experiment?
"Affirmative. Clinicaltrials.gov indicates that the recruitment process for this clinical trial, originally posted on October 10th 2021 and recently updated on August 26th 2022, is ongoing. The researchers need to acquire 60 participants from a single research facility."
Answered by AI
Are participants currently being sought for this experiment?
"Clinicaltrials.gov informs us that this medical trial is currently enrolling patients; the study was first posted on October 10th 2021 and has seen its most recent update take place on August 26th 2022."
Answered by AI
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