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Cell Therapy

SkinTE for Diabetic Foot Ulcers(COVER DFUs Trial)

Northwell Health, New York, NY
SkinTE +1 morePhase 3Waitlist AvailableLed by Lawrence Lavery, DPMResearch Sponsored by PolarityTE

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 below
You have good blood flow to the foot, which has been checked with specific measurements.
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 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.
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 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.

COVER DFUs Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 4, 8, 12, 16, 20, and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 4, 8, 12, 16, 20, and 24 weeks for reporting.

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 more
Other 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

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

SkinTE (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05372809 — Phase 3
Diabetic Foot Research Study Groups: SkinTE, Control
Diabetic Foot Clinical Trial 2023: SkinTE Highlights & Side Effects. Trial Name: NCT05372809 — Phase 3
SkinTE (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05372809 — Phase 3

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
~23 spots leftby Jun 2024