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DFUNCT07222540

Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers

A study testing SkinTE in people with DFU and Neuropathic Diabetic Ulcer - Foot, run by PolarityTE.

Temporarily Not Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this EAP is to provide access to SkinTE® for patients with Wagner I Diabetic Foot Ulcers (DFUs). SkinTE® is an autologous investigational product created from a healthy full-thickness skin harvest. SkinTE is applied directly to the wound with the goal of promoting healing. Read more about this study

Who is it for?
Any age
What is being tested?
SkinTE
How many people
Not given
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

Who may be able to join

  • ≥18 years of age
  • Subjects are medically optimized with a documented history of Type I or Type II Diabetes Mellitus requiring insulin and/or oral therapy.
  • Presence of a DFU Wagner 1 grade wound on any aspect of the foot, provided that if the malleolus is involved, not more than 50% of the wound is above the mid-point of the medial malleolus. Note: Index Ulcer must maintain Wagner grade 1 from screening to harvest procedure.
  • Index ulcer (i.e., current episode of ulceration) has been present for ≥ four weeks (≥ 28 days) prior to the initial screening visit.
  • If other wound(s) are present on the same foot, they must be more than 2 cm distant from the index ulcer.
  • Ulcer size between 1.0 cm² and 25 cm² post-debridement at screening and day of Harvest, which may occur 3 to 30 days after screening.
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  • Adequate circulation to the affected foot documented by a dorsal transcutaneous oxygen measurement (TCOM) or skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) of ≥ 0.7 and ≤ 1.2 or Arterial Doppler with a minimum of biphasic flow or Toe Brachial Index (TBI) ≥ 0.75 using the affected study extremity within 30 days of the screening visit.
  • Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines PEDIS Grade level 1.
  • The subject can comply with study visits, wound management, and follow-up regimen.
  • The treating investigator has determined that no suitable alternative therapy is available to adequately address the patient's medical needs.
  • Based on the treating investigator's clinical judgment and the severity of the patient's condition, the patient has the potential to derive meaningful benefits from the use of SkinTE.
  • Females of childbearing potential must agree to use effective methods of contraception (birth control pills, barriers, or abstinence) (Screening through End of Study (EOS) and undergo pregnancy tests.
  • Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile).
  • Properly obtained written informed consent.
  • Subjects who previously received SkinTE as part of a prior SkinTE-related trial may be considered for participation, provided a new index ulcer is selected for treatment on the contralateral limb and sponsor approval is granted.

Who cannot join

  • Participation in another investigational drug or therapeutic device trial within 30 days prior to screening.
  • Use of prohibited medication(s) as defined in this protocol.
  • Presence of diabetes with poor metabolic control, defined as a documented historical HbA1c ≥12.0% within 90 days prior to screening.
  • Subjects with a history of more than two weeks of treatment with immunosuppressants (including systemic corticosteroids > 10mg prednisone (or equivalent) daily dose), or cytotoxic chemotherapy prior to screening.
  • Index ulcer treated within 30 days of screening with prohibited treatment as defined in this protocol.
  • Subjects with presence of gangrene, unstable ischemia, or active Charcot's foot.
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  • Subjects with recent lower extremity revascularization within ≤30 days of screening.
  • Based on the treating investigators clinical judgement there is no suspicion of malignancy in the index ulcer.
  • History of osteomyelitis, cellulitis, or other soft tissue infections involving the index ulcer within 30 days of screening.
  • Subjects with exposed internal fixation on the same limb as the index ulcer. [Note: External fixation is allowed if deemed stable by principal investigator.]
  • Active infection of the index ulcer (as defined by IDSA PEDIS Grade 1 guidelines) of the affected limb.
  • History of radiation therapy on the affected limb.
  • Subject is pregnant or breastfeeding.

About this study

The purpose of this EAP is to provide access to SkinTE® for patients with Wagner I Diabetic Foot Ulcers (DFUs). SkinTE® is an autologous investigational product created from a healthy full-thickness skin harvest. SkinTE is applied directly to the wound with the goal of promoting healing.

In addition to providing treatment, the program will collect safety and efficacy data. This data will help us understand the potential risks and benefits of SkinTE® when used in a real-world setting. PolarityBio® provides research funding to the study site to support data collection.

Being tested
SkinTE
Keywords
DFU, PolarityBio, SkinTE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SkinTEBiological

    Also called Autologous Heterogeneous Skin Construct

    SkinTE is an Autologous Heterogeneous Skin Construct (AHSC), which is manufactured from a small piece of healthy full-thickness skin harvested from the patient at the time of randomization to the SkinTE arm. SkinTE is manufactured aseptically by PolarityBio following current Good Manufacturing Practice (cGMP). SkinTE is not cultured ex vivo; rather, it is returned to the provider expeditiously to maintain cellular viability. SkinTE contains multicellular aggregates that contain different types of skin cells, such as keratinocytes, dermal fibroblasts, dermal endothelial cells, and follicular cells, as well as extracellular matrix. The multicellular aggregates have a surface area-to-volume ratio for improved sustenance by imbibition prior to engraftment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT07222540
Sponsor's protocol ID
PolarityBio EAP - DFU 01
Status last verified
Oct 2025
First submitted
27 Oct 2025
Last updated
30 Oct 2025
Results posted
No

Publications

  • Armstrong DG, Orgill DP, Galiano R, Glat PM, Didomenico L, Sopko NA, Swanson EW, Sigal F, Snyder R, Li WW, Carter M, Zelen CM. A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis. Int Wound J. 2023 Dec;20(10):4083-4096. doi: 10.1111/iwj.14301. Epub 2023 Jul 4.

    PubMed 37402533

  • Armstrong DG, Orgill DP, Galiano R, Glat PM, Carter M, Zelen CM, Li WW. Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers. Int Wound J. 2020 Oct;17(5):1366-1375. doi: 10.1111/iwj.13404. Epub 2020 May 26.

    PubMed 32453512

Questions about this trial

What is this clinical trial studying?

A study testing SkinTE in people with DFU and Neuropathic Diabetic Ulcer - Foot, run by PolarityTE.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07222540, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.

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