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 treatmentof 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 beginningbelow 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 lessthan 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: Deepulcer extended to ligament, tendon, joint capsule, bone, or deep fascia withoutabscess or osteomyelitis Wagner Grade 3: Ulcers extend to the deep tissue and haveeither associated soft tissue abscess or osteomyelitis If Wagner Grade 3 Ulcer withchronic osteomyelitis, that can be debrided in an outpatient setting, in the opinionof the investigator

13. Exposed or palpable bone in the reference ulcer, that can be surgically excisedin an outpatient clinic setting, using local anesthetic, at the screening orrandomization visit

14. Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiringsurgical 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 orPositive probe to bone (PTB) test or Strong clinical suspicion, in the opinion ofthe Investigator, in the presence of osteomyelitis in the index wound

15. Subject does not require a surgical debridement in the operating room

16. Subjects without active cellulitis at the index ulcer

17. Subject or responsible caregiver is willing to comply with the dressing treatmentand study visits

18. Subject is willing to utilize the offloading device to offload wound

19. If female, subjects must have been practicing adequate contraception (abstinence,barrier method, hormonal, or IUD). Must agree to using an accepted and effectiveform of birth control during the study.

20. Subject has adequate circulation to the affected extremity, as demonstrated by atleast ONE of the following tests within 60 days (about 2 months) prior toenrollment:

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

Exclusion Criteria:

1. Subject is unwilling to sign informed consent

2. Subjects who cannot obtain insurance coverage for BBFGM

3. The BBFGM cannot be applied in an outpatient setting

4. Index ulcer has previously received an application of BBFGM

5. Subject has a major contralateral amputation of lower extremity, specificallytransmetatarsal amputation or more proximal amputation

6. Subject index ulcer has a known history of borate-base bioactive glass fiber matrixapplication

7. Subject is pregnant or breast-feeding.

8. Subject index ulcer associated with carcinoma.

9. Subject has active Charcot Neuroarthropathy

10. Subject requires extensive soft tissue and bone debridement in the operating room

11. Subject has a life expectancy of less than six months as assessed by theinvestigator.

12. Subject not in reasonable metabolic control in the judgment of the investigator

13. Subject with a known history of poor compliance with medical treatments

14. Subject currently undergoing cancer treatment

15. Subject has been on oral steroid use of <7.5 mg daily for greater than sevenconsecutive days in 30 days before screening

16. Subject is taking parenteral corticosteroids or any cytotoxic agents for sevenconsecutive days in the period of 30 days before screening

17. The subject has malignancy or a history of cancer, other than non-melanoma skincancer, in five years before screening

18. Subject has been diagnosed or had medical history with at least one of the followingdiseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquiredimmunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stagerenal disease.

19. Subject currently receiving radiation therapy or chemotherapy.

20. Patient currently on dialysis or planning to start dialysis.

21. Presence of any condition that is likely to impair understanding of or compliancewith the study protocol in the judgment of the Investigator

22. Subject is unable to sustain off-loading as defined by the protocol

23. Subject index ulcer that cannot be offload by an offloading device

24. Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and/orpresence of acute cellulitis at the index ulcer

25. Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the indexulcer during the study

26. Subjects who are permanently non-ambulatory (i.e. wheelchair bound)

27. The subject is a woman of child-bearing potential who is unwilling to avoidpregnancy or use an appropriate form of birth control (adequate birth controlmethods are defined as: topical, oral, implantable, or injectable contraceptives;spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; orsurgical sterilization of partner)

28. Subject has an allergy to primary or secondary dressing materials used in this trial

29. In the opinion of the Investigator the subject is not appropriate for inclusion inthe trial, e.g., undergoing surgical treatments listed in the protocol or subjectcurrently has sepsis, i.e., life threatening organ dysfunction caused by adysregulated host response to infection