Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers (NCT07222540) | Clinical Trial Compass
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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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.