Status:
TEMPORARILY_NOT_AVAILABLE
Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers
Lead Sponsor:
PolarityTE
Conditions:
DFU
Neuropathic Diabetic Ulcer - Foot
Eligibility:
All Genders
Brief 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 s...
Eligibility Criteria
Inclusion
- ≥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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT07222540
Last Update
October 30 2025
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