SkinTE for Diabetic Foot Ulcers

Recruiting at 20 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

100 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment SkinTE for diabetic foot ulcers?

Research shows that similar treatments, like tissue-engineered skin substitutes, have been effective in treating diabetic foot ulcers. Additionally, growth factors used in other treatments have shown promise in promoting healing in these types of wounds. ^{1 2 3 4 5}

How is the treatment SkinTE different from other treatments for diabetic foot ulcers?

SkinTE is unique because it is a tissue-engineered skin substitute that uses a patient's own skin cells to regenerate skin, potentially offering a more personalized and effective healing process compared to other treatments like dermal regeneration templates or silver-releasing dressings. ^{1 6 7 8 9}

What is the purpose of this trial?

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.

Research Team

Nikolai Sopko, MD, PhD

Principal Investigator

PolarityBio

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Early identification of delayed wound healing in complex diabetic foot ulcers treated with a dermal regeneration template: A novel clinical target and its risk factors. [2023]

2. England pubmed.ncbi.nlm.nih.gov

New treatments in ulcer healing and wound infection. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Topical Recombinant Human Epidermal Growth Factor for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Controlled Clinical Trials. [2020]

4. Australia pubmed.ncbi.nlm.nih.gov

Diabetic foot ulcer burden may be modified by high-dose atorvastatin: A 6-month randomized controlled pilot trial. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Cellular versus acellular matrix devices in the treatment of diabetic foot ulcers: Interim results of a comparative efficacy randomized controlled trial. [2020]

6. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Marine Isopod Ceratothoa Oestroides Extract: a Novel Treatment for Diabetic Foot Ulcers? Case Report of an Immunosuppressed Patient. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Sustained silver-releasing dressing in the treatment of diabetic foot ulcers. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

New Therapies for the Treatment of Diabetic Foot Ulcers: Updated Review of Clinical Trials. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

The cost effectiveness of Apligraf treatment of diabetic foot ulcers. [2022]