Placenta Stem Cells for Foot Ulcer

MD
Overseen ByMary-Clare Day, RN
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to test the safety of placental stem cells to treat non-healing diabetic foot ulcers.

Who Is on the Research Team?

LG

Lucian G. Vlad, MD

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

This trial is for people with diabetes who have foot ulcers that are not healing. Participants should be adults and meet specific health requirements set by the study team.

Inclusion Criteria

I have a single diabetic foot ulcer larger than 2 cm² that hasn't healed in four weeks.
I am willing to avoid steroids for one week before the procedure.
I have not started any new diabetes medication in the past 2 weeks.
See 1 more

Exclusion Criteria

I have severe peripheral artery disease with poor blood flow in my legs or feet.
I am currently taking medications that suppress my immune system.
Hemoglobin A1C >12.0 at screening or time in range (TIR) for blood glucose less than 30%, with exceptions for hypoalbuminemia, anemia in past 3 months, and CKD stage 4 patients
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • Placenta Stem Cells

Trial Overview

The study is testing whether placental stem cells are safe to use as a treatment for diabetic foot ulcers that haven't healed with standard care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Diabetic with Foot UlcerExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+