TEMPORARILY_NOT_AVAILABLENot Applicable

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

Plain-language 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. 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.

Who can participate

SexALL

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Inclusion criteria

✓. ≥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.

Exclusion criteria

✕. 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.

Trial details

NCT IDNCT07222540

SponsorPolarityTE

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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