Mirragen Diabetic Foot Ulcer Study

Inclusion Criteria

• •1. The subject has signed the informed consent form
• •2. Subject is male or female aged between ≥ 18 or ≤ 80
• •3. Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer
• •4. Index ulcer has not received an application of BBFGM previously
• •5. Subjects with insurance coverage for BBGFM
• •6. Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.
• •7. The subject is under the care of Physician for the management of Diabetes Mellitus
• •8. Subject must have a wound present anatomically on the foot as defined by beginning below the malleoli of the ankle, dorsal surface, plantar surface, inter digital, heel, lateral or medial surface of the foot
• •9. Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2
• •10. Index ulcer has been present for greater than 4 weeks prior to enrollment and less than 2-years, as of the date the subject receives the BBGFM
• •11. The BBGFM will be applied in an outpatient setting
• •12. Subject has an ulcer with a Wagner Grade 2 or 3 classification Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis Wagner Grade 3: Ulcers extend to the deep tissue and have either associated soft tissue abscess or osteomyelitis If Wagner Grade 3 Ulcer with chronic osteomyelitis, that can be debrided in an outpatient setting, in the opinion of the investigator
• •1. Exposed or palpable bone in the reference ulcer, that can be surgically excised in an outpatient clinic setting, using local anesthetic, at the screening or randomization visit
• •2. Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit
• •Wagner Grade 3 subjects must have osteomyelitis diagnosed by:
• •X-ray: suggestive or positive for changes consistent with chronic osteomyelitis or Positive probe to bone (PTB) test or Strong clinical suspicion, in the opinion of the Investigator, in the presence of osteomyelitis in the index wound
• •13. Subject does not require a surgical debridement in the operating room
• •14. Subjects without active cellulitis at the index ulcer
• •15. Subject or responsible caregiver is willing to comply with the dressing treatment and study visits
• •16. Subject is willing to utilize the offloading device to offload wound
• •17. If female, subjects must have been practicing adequate contraception (abstinence, barrier method, hormonal, or IUD). Must agree to using an accepted and effective form of birth control during the study.
• •18. Subject has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following tests within 60 days (about 2 months) prior to enrollment:
• •A.Ankle-Brachial Index (ABI) of study leg(s) of ≥0.7 to ≤1.3 in conjunction with doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg Or B.Toe brachial Index (TBI) of ≥ 0.50 OR C.Great Toe Pressure 50mmHg OR D.Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) of ≥40mmHg on the dorsum of the affected foot OR E.Palpable pulses