Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care

This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention.

This is a prospective, two-armed, multi-center randomized controlled trial (RCT) comparing Cytal Wound Matrix 1-Layer intervention to standard of care (SOC) intervention in patients presenting with diabetic foot ulcers (DFU). Up to one hundred and fifty patients recruited from US based medical centers and randomized (using a 2(active):1(control) randomization scheme) to receive either Cytal Wound Matrix 1-Layer intervention or standard of care intervention.Complete wound closure incidence, wound healing rates, wound recurrence, and various health related quality of life (HRQOL) outcomes will be compared between study arms. Additionally, a cost effective analysis (i.e. direct and indirect costs) and review of individual and group changes in narcotic prescription patterns will also be evaluated. While incidence of wound closure rates will be evaluated through 12 weeks, protocol defined patient follow-up is for two years.

Data will be captured for remaining study objectives during these two years. An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee (CEC) will adjudicate all adverse events (AEs) and serious adverse events (SAEs).

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form by subject or legally authorized representative.
2. Stated willingness to comply with all study procedures and availability for the duration of the study. Subject is able and willing to tolerate non-removable offloading device for the duration of the run-in and intervention phases of the study.
3. Subject is male or female and at least 21years of age.
4. Subject has a clinical diagnosis of type 1 or type 2 diabetes.
5. Subject's current foot ulcer(s) has been present for \> 30 days and ≤ 365 days.
6. Subject's current foot ulcer(s), post-debridement is/are predominantly below the malleoli and on the plantar surface of the foot.
7. Subject's foot ulcer(s) must be Wagner type 1 or type 2.
8. Post debridement, subject's ulcer(s) are free of necrotic debris and appear to be comprised of healthy, vascularized tissue.
9. All qualifying ulcers are ≥ 5cm away from any other ulcer on the same foot.
10. Subject's ulcer(s) is ≥ 1cm2 and ≤ 20cm2 at randomization (length x width).
11. Subject's HbA1C reading is ≤10%.
12. Subject's Serum Creatinine ≤ 3.0mg/dL.
13. Subject has adequate circulation to the foot as measured by Ankle-Brachial Index (ABI) ≥ 0.7.
14. Negative pregnancy test at randomization for women.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Subject is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
2. Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
3. Subject report of concurrent participation in another clinical trial that involves a drug.
4. The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.
5. Subject has clinical evidence of gangrene on any part of the affected foot.
6. The subject's ulcer(s) is/are due to a non-diabetic etiology, ulcers of arterial, venous stasis, pressure, radiation, traumatic, rheumatoid, vasculitis, collagen vascular disease, or other non-diabetic etiologies.
7. Subject has unstable Charcot foot, Charcot foot with a bony prominence(s) or Charcot amputation.
8. Qualifying wound(s) is connected to another ulcer via a fistula.
9. Subject has one or more medical condition(s) including: renal, hepatic, hematological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this wound healing study.
10. Subject has or has had a malignant disease (other than basal cell carcinoma) that has not been in remission for at least five years.
11. Subject is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such during the course of the study.
12. Subject has acute osteomyelitis of the affected foot.
13. Subject's ulcer(s) is accompanied by active cellulitis.
14. Subject has received growth factor or enzymatic therapy within 2 weeks of consent.
15. Subject is currently receiving or has received radiation, radiologic implants, or chemotherapy.
16. Subject is allergic to any of the primary or secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
17. Subject's ulcer(s) has decreased in size by \>30% during the run-in phase.
18. Subject's ulcer(s) has increased in size by \>50% during the run-in phase.
19. Subject's ulcer(s) has tunnels or sinus tracts that cannot be completely debrided.
20. Subject has severe malnutrition as evidenced by albumin \<2.0 g/dL.
21. Subject has a bleeding disorder as documented by a diagnosis of a bleeding disorder.
22. Subject is on dialysis.
23. Any DFU(s) is infected and has not been treated for any clinically suspected infection prior to application of any product.