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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate circulation to the affected foot as documented by specific measurements
Negative pregnancy test for females of childbearing potential
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upassessed at 4, 8, 12, 16, 20, and 24 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
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.
COVER DFUs Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have good blood flow to the foot, which has been checked with specific measurements.
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Women who could become pregnant need to have a negative pregnancy test.
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The wound where the treatment will be placed should not have any dead tissue or signs of infection.
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You have been diagnosed with Type I or Type II diabetes and need to take pills or insulin to manage it.
Select...
You have a specific type of wound on your foot.
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If you had an infection in the area of the ulcer, it must be treated and under control.
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The ulcer being studied has been protected with a specific device during the study's preparation period.
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You have had the ulcer for at least four weeks before the first screening visit.
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The size of the ulcer will be checked at the first screening visit and the first randomization visit.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a wound or limb with gangrene or unstable blood flow.You had surgery to improve blood flow in your leg where the wound is located within the last 30 days.The sore looks like it might be cancerous, and the doctor wants to do a biopsy to check.You have had radiation treatment on the same limb as the wound being studied.You have metal implants in the same limb where the wound is located.You have had treatment for a certain type of ulcer in the last 30 days before screening.You have taken certain medications that weaken the immune system or received specific types of chemotherapy in the past two weeks.You have a condition called Charcot's arthropathy in the limb with the problem ulcer.You have a long-term bone infection or skin infection on the same arm or leg as the main wound.You have severe kidney disease and need dialysis.You have good blood flow to the foot, which has been checked with specific measurements.You have signs of uncontrolled HIV, hepatitis B, or hepatitis C.Women who could become pregnant need to have a negative pregnancy test.The wound where the treatment will be placed should not have any dead tissue or signs of infection.You have diabetes that is not well managed.You have been diagnosed with Type I or Type II diabetes and need to take pills or insulin to manage it.You have a specific type of wound on your foot.The size of the ulcer has changed by 30% or more after 14 days of standard treatment.If you had an infection in the area of the ulcer, it must be treated and under control.The ulcer being studied has been protected with a specific device during the study's preparation period.You have a history of severe heart failure or unstable heart disease needing treatment.You need surgery (except for cleaning wounds) when you agree to join the study, or you are likely to need surgery during the study.You have had the ulcer for at least four weeks before the first screening visit.The size of the ulcer will be checked at the first screening visit and the first randomization visit.
Research Study Groups:
This trial has the following groups:- Group 1: SkinTE
- Group 2: Control
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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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