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Cell Therapy
Skin Cell Transplant for Diabetic Foot Ulcers (COVER DFUs Trial)
Phase 3
Waitlist Available
Led By Lawrence Lavery, DPM
Research Sponsored by PolarityTE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Index ulcer (post-debridement) is a minimum of 1.0 cm2 and a maximum of 10 cm2 at the first screening visit and first randomization visit
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 4, 8, 12, 16, 20, and 24 weeks
Awards & highlights
COVER DFUs Trial Summary
This trial will test whether SkinTE, a skin cell transplant, is safe and effective for treating Wagner grade 2 diabetic foot ulcers.
Who is the study for?
Adults with Type I or II Diabetes and a stable Wagner grade 2 diabetic foot ulcer between 1.0 cm2 and 10 cm2, who can attend weekly visits. They must have good blood flow to the foot, no recent major surgeries on the limb, not be pregnant or breastfeeding, and agree to use contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial is testing SkinTE's safety and effectiveness in healing diabetic foot ulcers compared to standard care. Participants are randomly assigned to receive either SkinTE treatment or control treatment for their ulcers.See study design
What are the potential side effects?
While specific side effects of SkinTE are not listed here, treatments like this may cause skin irritation, infection at the application site, allergic reactions or fail to improve the wound which could lead to further medical procedures.
COVER DFUs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My wound is between 1.0 and 10 cm2 after cleaning.
Select...
I am 18 years old or older.
Select...
I have diabetes and take pills or insulin for it.
Select...
I have a type 2 diabetic foot ulcer.
Select...
My wound is clean and free of infection.
Select...
My ulcer has been treated with a specific device as required.
Select...
My affected foot has good blood flow.
COVER DFUs Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at 4, 8, 12, 16, 20, and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 4, 8, 12, 16, 20, and 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Incidence of index ulcers closed
Percent area reduction (PAR)
Time to closure
+2 moreOther outcome measures
Incidence of adverse events of the index ulcer
Incidence of pain, infection, and complications of the harvest site
COVER DFUs Trial Design
2Treatment groups
Experimental Treatment
Group I: SkinTEExperimental Treatment1 Intervention
SkinTE plus standard care
Group II: ControlExperimental Treatment1 Intervention
Standard care alone
Find a Location
Who is running the clinical trial?
PolarityTELead Sponsor
3 Previous Clinical Trials
229 Total Patients Enrolled
2 Trials studying Diabetic Foot
200 Patients Enrolled for Diabetic Foot
Alira HealthUNKNOWN
3 Previous Clinical Trials
368 Total Patients Enrolled
Nikolai Sopko, MD, PhDStudy DirectorPolarityTE
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Diabetic Foot
100 Patients Enrolled for Diabetic Foot
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active Charcot's disease in the limb with the ulcer, confirmed by recent tests.I have severe heart failure or had a recent heart procedure.I haven't used strong immune system drugs, cancer drugs, or steroid creams on my ulcer for 30 days.I have a stable place to live where I can manage my wound care.My wound is between 1.0 and 10 cm2 after cleaning.Women who could become pregnant must have a negative pregnancy test.I had surgery to improve blood flow in my leg with the ulcer within the last 30 days.My ulcer has been treated with a specific device as required.I have diabetes and take pills or insulin for it.My ulcer or the limb with the ulcer had infections, but they are now under control.My wound is clean and free of infection.My ulcer or limb has gangrene or unstable blood flow.You have metal implants in the same limb as the wound being studied.I have had radiation therapy on the same limb as my current ulcer.You have signs of uncontrolled HIV, hepatitis B, or hepatitis C according to the doctor at your first screening visit.My doctor suspects my ulcer might be cancerous and recommends a biopsy.My ulcer has not been treated with any prohibited methods in the last 30 days.My diabetes is not well-controlled, with a recent HbA1c level of 12.0 or higher.I have severe kidney disease and am on dialysis or have an eGFR under 30.I need surgery or might need it during the study.I am 18 years old or older.I have chronic bone infection or skin infection in the same limb as my main wound, confirmed by a doctor or imaging recently.My ulcer has been present for 4 weeks or more.I have a type 2 diabetic foot ulcer.My ulcer size changed by 30% or more after 2 weeks of standard treatment.My affected foot has good blood flow.
Research Study Groups:
This trial has the following groups:- Group 1: SkinTE
- Group 2: Control
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
How many different people will be given this treatment in total?
"Indeed, the clinical trial described is currently recruiting patients, as of 10/25/2022. The study was first posted on 4/28/2022, and is looking for 100 individuals at 2 different sites."
Answered by AI
Is this study still enrolling participants?
"That is correct. According to the information on clinicaltrials.gov, this study is still looking for participants. The trial was originally posted on 4/28/2022 and was last updated on 10/25/2022. They are hoping to enroll 100 patients from 2 locations."
Answered by AI
Could you please share the risks associated with SkinTE?
"Similar to other products at its stage in development, SkinTE has received a 3 for safety. This is based on the amount of data supporting its efficacy and safety that has been collected thus far."
Answered by AI
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