SkinTE for Diabetic Foot Ulcers

Not currently recruiting at 22 trial locations

Overseen By Ashlee Fishleigh

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: PolarityTE

Must be taking: Oral diabetes medications

Must not be taking: Immunosuppressants, Chemotherapy, Topical steroids

Disqualifiers: Gangrene, Cancer, Radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests SkinTE, a new treatment for diabetic foot ulcers. The goal is to determine if SkinTE is safe and effective for healing these sores compared to standard care alone. Individuals with Type I or Type II diabetes who have had a diabetic foot ulcer for at least four weeks may qualify. Participants will receive either SkinTE with their usual care or their usual care alone. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on investigational drugs or certain treatments like immunosuppressants, you may need to stop them before joining the study.

Is there any evidence suggesting that SkinTE is likely to be safe for humans?

Research has shown that SkinTE has been tested in earlier studies for treating diabetic foot ulcers, providing some information about its safety. Participants in these studies generally tolerated SkinTE well, with no serious side effects reported. The treatment aims to help the body heal wounds by growing new skin and nearby tissues, essentially boosting the body's natural healing process.

Additionally, the FDA has granted SkinTE "Breakthrough Therapy" status for diabetic foot ulcers, indicating promise in early testing. While this designation does not guarantee safety, it suggests that SkinTE has shown potential benefits that outweigh risks in studies so far.

Overall, current data suggests SkinTE is safe, but it is important to remember that every treatment can affect individuals differently. Joining a clinical trial helps gather more safety data, and researchers closely monitor participants throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic foot ulcers?

Unlike the standard care for diabetic foot ulcers, which typically involves wound cleaning, dressings, and sometimes antibiotics, SkinTE is a regenerative skin technology that uses a patient's own skin to create a personalized treatment. This innovative approach is designed to promote healing by delivering a combination of cells that can help regenerate damaged tissue. Researchers are excited about SkinTE because it offers the potential for faster, more effective healing compared to traditional methods, potentially reducing the risk of complications like infections or amputations.

What evidence suggests that SkinTE might be an effective treatment for diabetic foot ulcers?

Research has shown that SkinTE, which participants in this trial may receive, may help heal diabetic foot ulcers. In earlier studies, SkinTE successfully rebuilt and activated the tissue around the wound, leading to the complete healing of certain diabetic foot ulcers. The FDA recognized SkinTE as a Breakthrough Therapy due to its potential benefits. These findings suggest that SkinTE could be a strong option for people with these foot ulcers. ^{2 3 5 6 7}

Who Is on the Research Team?

Nikolai Sopko, MD, PhD

Principal Investigator

PolarityBio

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type I or II Diabetes who have a specific type of foot ulcer (Wagner grade 1) that's been present for at least four weeks. The ulcer must be between 1 and 15 cm2 in size, not too close to other ulcers, and the person must have good blood flow to their foot. Pregnant women can't participate.

Inclusion Criteria

I have a grade 1 diabetic foot ulcer not mostly above my ankle.

Any other sores on the same foot are at least 2 cm away from my main ulcer.

I have diabetes and take pills or insulin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive SkinTE with standard of care or standard care alone for the treatment of diabetic foot ulcers

12 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Weekly visits

What Are the Treatments Tested in This Trial?

Interventions

• SkinTE

Trial Overview The study is testing SkinTE, a new treatment for diabetic foot ulcers against a control group. It aims to see if SkinTE is safe and works well in healing these ulcers compared to standard care.

How Is the Trial Designed?

Group I: SkinTE Experimental Treatment 1 Intervention

SkinTE plus standard care

Group II: Control Experimental Treatment 1 Intervention

Standard care alone

Who Is Running the Clinical Trial?

PolarityTE

Lead Sponsor

Trials

4

Recruited

270+

Professional Education & Research Institute

Collaborator

Trials

1

Recruited

100+

Professional Education and Research Institute

Collaborator

Trials

16

Recruited

1,400+

Published Research Related to This Trial

In a study of 27 patients with diabetic foot ulcers, the sustained silver-releasing foam dressing, Contreet Foam, demonstrated effective healing, with an average healing rate of 56% over four weeks of treatment.

Contreet Foam was found to be safe, easy to use, and effective in managing exudate, with no device-related adverse events reported during the six-week study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained silver-releasing dressing in the treatment of diabetic foot ulcers. Rayman, G., Rayman, A., Baker, NR., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03881254?intr=SkinTE&rank=4

SkinTE™ in the Treatment of Diabetic Foot Wounds This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous ...

2. pharmacytimes.com pharmacytimes.com/view/fda-grants-breakthrough-therapy-designation-to-skinte-for-diabetic-foot-ulcers

FDA Grants Breakthrough Therapy Designation to SkinTE ... SkinTE could aid Wagner grade 1 diabetic foot ulcers by regenerating and activating the tissues surrounding the wound to heal it completely.

3. cgtlive.com cgtlive.com/view/first-patient-diabetic-foot-ulcers-screened-skinte-pivotal-trial

First Patient With Diabetic Foot Ulcers Screened for SkinTE ... “There was a serious discrepancy in results between DPN 3-1 and DPN 3-1b; only the latter study replicated results from the phase II study.

4. biospace.com biospace.com/press-releases/polaritybio-completes-enrollment-in-the-phase-iii-pivotal-study-of-skinte-for-diabetic-foot-ulcers

PolarityBio Completes Enrollment in the Phase III Pivotal ... The trial has enrolled 120 patients across multiple U.S. clinical sites in just 14 months, at an average of 8.6 patients per month, outpacing ...

5. withpower.com withpower.com/trial/phase-3-diabetic-foot-2024-47ac2

SkinTE for Diabetic Foot Ulcers · Info for Participants In a study of 27 patients with diabetic foot ulcers, the sustained silver-releasing foam dressing, Contreet Foam, demonstrated effective healing, with an ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07222540

Expanded Access Program Evaluating SkinTE in the ... The purpose of this EAP is to provide access to SkinTE® for patients with Wagner I Diabetic Foot Ulcers (DFUs). ... safety and efficacy data ...

7. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36377

LCD - Skin Substitute Grafts/Cellular and Tissue-Based ... Diabetic foot ulcers may affect up to 6% of Medicare beneficiaries with either Type I or Type II diabetes. Chronic wounds such as DFUs and VLUs impact patient ...