TruSkin®: Study for the Treatment of Chronic Diabetic Foot Ulcers

A Multicenter, Randomized, Single-Blind Study Comparing the Clinical Outcomes of TruSkin® and an Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers

The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic diabetic foot ulcers.

Inclusion Criteria:

1. Between 18 years and 80 years of age inclusive, as of the date of screening
2. Confirmed diagnosis of Type 1 or Type 2 Diabetes
3. An Index Ulcer that is chronic (defined as present for > 4 weeks, but not present for more than 52 weeks at the Screening Visit)
4. Index Ulcer is located below the malleolus
5. The Index Ulcer is a Diabetic Foot Ulcer (DFU) greater than 3 cm2, inclusive, at the Screening Visit
6. The longest length and longest width measurements for the Index Ulcer are no less than 1 cm each at the Screening Visit
7. The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
8. Wound is free of necrotic debris
9. Patient has adequate circulation to the foot as documented by ABI or TBI

Exclusion Criteria:

1. Index Ulcer is of non-diabetic pathophysiology
2. Gangrene is present on any part of the affected foot
3. Index Ulcer is over a Charcot deformity
4. Patient is currently receiving dialysis or planning to go on dialysis
5. Patient has a glycated hemoglobin A1c (HbA1c) level of >12%
6. Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening
7. Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
8. Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
9. Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
10. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
11. Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
12. Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
13. Patient has active malignancy other than non-melanoma skin cancer
14. Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period
15. Patient's random blood sugar is > 450 mg/dl at screening
16. Patient is unable to properly off-load the index wound as a part of standard of care
17. Patient has untreated alcohol or substance abuse at the time of screening
18. Pregnant women and women who are breastfeeding
19. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
20. Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies
21. Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
22. Patients who have already been randomized in Protocol 351 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Study Visit
23. Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol