Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

Exclusion Criteria

• •1. Suspected or confirmed signs/symptoms of wound infection (subjects may be rescreened if the infection has been treated.) Infection is defined as, for example:
• •i. purulence, erythema, cellulitis, excessively high temperatures in/around the ulcer, atypical smell, and/or excessive pain in/around the ulcer (infection may be treated and subject reconsidered for study participation).
• •ii. osteomyelitis, with necrotic soft bone. (x-ray to be obtained if in the opinion of the investigator additional confirmation of diagnosis required)
• •2. Patients presenting with an ulcer probing to tendon, capsule or bone (University of Texas Grade 2 or 3 or deep Wagner 2 or 3).
• •3. Hypersensitivity to silver or fresh frozen plasma.
• •4. The subject was previously entered into this study or had participated in any study drug or medical device study within 30 days of screening.
• •5. Currently on a treatment regimen or medications which in the opinion of the investigator are known to interfere with wound healing (for example: cancer chemotherapy or equivalent immunosuppressants, systemic steroids \> 10 days of treatment, cytostatic drugs, cyclooxygenase-2 inhibitors, or radiation therapy).
• •6. Excessive lymphedema that in the opinion of the investigator will interfere with wound healing.
• •7. A cognitive, physical, or psychological condition interfering with subject's ability to comply with the treatment regimen.
• •8. Active Charcot foot or unstable Charcot that in the opinion of the investigator will inhibit wound healing.
• •9. Wounds secondary to vasculitis, neoplasms, or hematological disorders. Patients on anticoagulation medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
• •10. An ulcer that in the opinion of the investigator is not associated with the subject's diabetic neuropathic condition.
• •11. Subjects is on dialysis.
• •12. History of radiation to the target foot.
• •13. Patients with uncontrolled autoimmune connective tissue diseases.
• •14. Patients who are pregnant, breast feeding, or unwilling to practice contraceptive methods during participation in the study, if applicable. Effective methods of contraception include:
• •i. oral, injectable, or implanted hormonal contraceptives ii. intrauterine device or system, iii. barrier method with spermicide, or iv. bilateral tubal occlusion.
• •15. Patients with uncontrolled anemia (Hgb\<10 g/dL in women; \<12 g/dL in men) at Screening.
• •16. Severe malnutrition (serum albumin ≤2.0 with a normal C-reactive protein).
• •17. Wounds healed by \>30% in area following the 2-week, active run-in period as measured during Visit 3.
• •18. Use of hyperbaric oxygen, and active dressings that include growth factors, engineered tissues, or skin substitutes (e.g., Regranex, Dermagraft, Apligraf, etc.) within 30 days of study screening.
• •19. Wounds \>5 mm deep after sharp debridement.
• •20. Clinical suspicion of skin cancer at or near the ulcer location which has not been ruled out by biopsy.