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Synthetic Dermal Matrix
SynPath for Diabetic Foot Ulcers (DFUs Trial)
N/A
Waitlist Available
Research Sponsored by PolyNovo Biomaterials Pty Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Reference ulcer has been diagnosed as either a partial or full thickness diabetic foot ulcer without tunneling, undermining, sinus tracts or /exposed bone, with a scale rating of a Wagner Grade 1 or Wagner Grade 2 extended to ligament, tendon, and joint capsule with no bone exposure
Ulcer is either located on the foot or ankle with at least 50% of ulcer below medial aspect of the malleolus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
DFUs Trial Summary
This trial will evaluate whether or not SynPath™ is more effective than Standard of Care in treating diabetic foot ulcers.
Who is the study for?
Adults with Type 1 or Type 2 diabetes and chronic foot ulcers that haven't improved with previous treatments can join this trial. They must have an ulcer on the foot or ankle, be willing to use birth control if applicable, and able to follow the study's procedures including dressing changes and off-loading.Check my eligibility
What is being tested?
The trial is testing SynPath™, a synthetic dermal matrix for diabetic foot ulcers against Standard of Care treatment which includes collagen-alginate wound dressings. Participants are randomly assigned to either receive SynPath™ or the standard treatment.See study design
What are the potential side effects?
Potential side effects may include local reactions at the site of application like redness, pain, possible allergic reactions if sensitive to polyurethane in SynPath™, or infection signs such as increased redness and purulent drainage.
DFUs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diabetic foot ulcer is shallow, without deep openings or exposed bone, and is classified as Wagner Grade 1 or 2.
Select...
My ulcer is on my foot or ankle, mostly below the inner ankle bone.
Select...
My ulcer is between 1cm² and 25cm² in size after cleaning.
Select...
My foot ulcer is at least 1cm away from any other ulcers after cleaning.
Select...
I or my caregiver can follow the dressing change and care plan for my ulcer.
DFUs Trial 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
Percentage of ulcer closed at 12 weeks
Secondary outcome measures
Change in reported Pain Levels between each treatment group
Comparison of closure rates for each treatment group
Cost of treatment in each treatment group
+3 moreDFUs Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NovoSorb SynPathExperimental Treatment1 Intervention
Arm receives application on NovoSorb SynPath Dermal Matrix and appropriate Off-loading
Group II: Standard of CareActive Control1 Intervention
Arm receives application of wound dressing composed of 90% Collagen and 10% Alginate plus appropriate Off-loading
Find a Location
Who is running the clinical trial?
PolyNovo Biomaterials Pty Ltd.Lead Sponsor
3 Previous Clinical Trials
175 Total Patients Enrolled
Charles M Zelen, DPM, FACFACStudy DirectorProfession Education and Research Institute, LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have conditions, other than diabetes, that could affect wound healing.I had a bone infection in my foot but have been treated and it's been over 8 weeks.I have had bone cancer, cancer spread to my limb, foot radiation, or chemotherapy within the last year.I have used or will use advanced wound dressings within 30 days.You have had a bad reaction to polyurethane in the past.I have signs of infection or gangrene in a limb, confirmed by tests.I have not been in a clinical trial for a device or drug within the last 30 days.I have ulcers caused by a condition that is not diabetes.I have received Negative Pressure Wound Therapy within the last 3 days.I am currently undergoing dialysis treatment.I am 18 years old or older.I am willing to use birth control or abstain from sex and take pregnancy tests during the study.My ulcer is on my foot or ankle, mostly below the inner ankle bone.I have taken, or will take, a medication that affects wound healing within the last 30 days.I have diabetes with an HbA1c level of 12% or less.I have a recent, non-healed surgical wound from an amputation on my limb.I have recently had or will have oxygen therapy.According to the doctor, you have a foot condition that is not stable or is causing ongoing problems.My wound is currently infected.I haven't used strong immune system suppressing drugs for more than two weeks recently.My ulcer is between 1cm² and 25cm² in size after cleaning.I or my caregiver can follow the dressing change and care plan for my ulcer.Blood flow in my limb is confirmed to be adequate through specific tests.My diabetic foot ulcer is shallow, without deep openings or exposed bone, and is classified as Wagner Grade 1 or 2.My wound did not shrink more than 30% after 2 weeks of standard care and offloading.My ulcer has not healed in over 4 weeks despite previous treatments.I have received an organ transplant.The investigator thinks there might be cancer in the ulcer and wants to do a biopsy to check for it.My foot ulcer is at least 1cm away from any other ulcers after cleaning.The doctor thinks that your severe swelling might make it hard for wounds to heal.
Research Study Groups:
This trial has the following groups:- Group 1: NovoSorb SynPath
- 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.
Wound Healing Patient Testimony for trial: Trial Name: NCT05506215 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research facilities are currently involved in this experiment?
"Currently, seven medical sites are recruiting patients for this trial. These clinics can be found in Youngstown, Vista and Fresno as well as four other locations. When considering participation, it is wise to select the closest option so you can avoid excess travel costs."
Answered by AI
Is this research study currently recruiting participants?
"According to clinicaltrials.gov, this research project is currently enrolling patients. The trial was first made public on July 10th 2022 and most recently revised on October 7th of the same year."
Answered by AI
How many participants are currently engaged in this research endeavor?
"To complete this trial, 138 qualified participants are necessary. Those interested can join at either the Lower Extremity Institute for Research and Therapy in Youngstown, Ohio or ILD Research Center in Vista, California."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Center for Clinical Research
ILD Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I've tried other medications that didn't work.
PatientReceived 2+ prior treatments
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