Placenta Stem Cells for Foot Ulcer

MD
Overseen ByMary-Clare Day, RN
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?

This trial aims to determine if placental stem cells can safely treat diabetic foot ulcers that resist healing. Participants must have Type 2 diabetes for at least a year and a foot ulcer that hasn't improved for over four weeks, despite standard treatments like special casts or wraps. Candidates should not have changed their diabetes medication in the last two weeks. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Is there any evidence suggesting that placenta stem cells are likely to be safe for humans?

Research has shown that placenta stem cells are generally safe for treating diabetic foot ulcers. One study found no serious side effects from these cells and reported complete healing in 38.5% of cases, compared to 22.6% with a placebo. Another study noted faster wound healing with placenta stem cell treatments. While the results are promising, the long-term safety and benefits remain under investigation. Overall, evidence suggests that placenta stem cells could be a safe option for improving wound healing in diabetic foot ulcers.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for diabetic foot ulcers, which typically involve wound care, antibiotics, and sometimes surgery, placenta stem cells offer a novel approach by promoting healing at the cellular level. These stem cells have the potential to regenerate damaged tissue and improve blood flow, addressing the root cause of non-healing ulcers. Researchers are excited about this treatment because it could significantly speed up the healing process and reduce complications for patients with diabetic foot ulcers, offering a promising alternative to existing care methods.

What evidence suggests that placenta stem cells might be an effective treatment for diabetic foot ulcers?

Research has shown that stem cells from the placenta may help heal stubborn diabetic foot sores. In one study, 51 out of 59 patients experienced complete healing of their sores within six months. Another study found that treatments using placenta cells accelerated wound healing and improved overall outcomes. In this trial, participants with type 2 diabetes and non-healing foot ulcers will receive placenta stem cell treatment to evaluate its effectiveness. These stem cells have proven particularly effective, with some sores healing entirely in just three weeks. Overall, these treatments appear to speed up healing and reduce the risk of major amputations.14567

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive placental stem cells to treat non-healing diabetic foot ulcers

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of diabetic foot ulcer healing and diabetic peripheral neuropathy

12 months
Visits at Months 1, 3, 6, and 12

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+

Citations

Human Placenta‐Derived Cells (PDA‐002) in Diabetic Foot ...

For the secondary endpoints, among patients with PAD, complete wound closure of the index ulcer within 6 months was achieved by 13 patients (50.0%) in the 3 × ...

Placental Tissue Therapies for Diabetic Foot Ulcers

Studies found quicker closure of wounds, shorter healing times, and better outcomes with these treatments.

Impacts of stem cells from different sources on wound ...

This study shows that stem cell therapy may be a promising method to promote wound healing in patients with diabetes foot ulcers, but its effectiveness varies ...

Stem Cells Show Promise for Nonhealing Diabetic Foot ...

At 6 month evaluations, 51 of 59 patients had 100% diabetic foot ulcer closure and the remaining 8 had closure of 75% or more. At 12 months, 50 ...

Diabetic Foot Ulcers and Placental Cells

placenta-derived stem cells have shown particularly promising results in DFU treatment research. the patient's foot ulcer was completely healed after 3 weeks. ...

Placental Cells for Diabetic Foot Ulcers - ClinicalTrials.Veeva

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

Diabetic Foot Ulcers and Placental Cells

More than 4 in 10 people who have a foot ulcer will die within five years. safety of placenta cells in wound repair and improving the rate of wound healing. ...