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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 CriteriaYou will be eligible if you check “Yes” for the criteria below
COVER DFUs Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
COVER DFUs Trial Design
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Who is running the clinical trial?
- 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.
- Group 1: SkinTE
- Group 2: Control
- 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.
- 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
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."
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."
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."
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