Mirragen Diabetic Foot Ulcer Study

Inclusion criteria

• The subject has signed the informed consent form
• Subject is male or female aged between ≥ 18 or ≤ 80
• Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer
• Index ulcer has not received an application of BBFGM previously
• Subjects with insurance coverage for BBGFM
• Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.
• The subject is under the care of Physician for the management of Diabetes Mellitus
• 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
• Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2
• 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
• The BBGFM will be applied in an outpatient setting
• 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
• 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
• 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
• Subject does not require a surgical debridement in the operating room
• Subjects without active cellulitis at the index ulcer
• Subject or responsible caregiver is willing to comply with the dressing treatment and study visits
• Subject is willing to utilize the offloading device to offload wound
• 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.
• 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

Exclusion criteria

• Subject is unwilling to sign informed consent
• Subjects who cannot obtain insurance coverage for BBFGM
• The BBFGM cannot be applied in an outpatient setting
• Index ulcer has previously received an application of BBFGM
• Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation
• Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application
• Subject is pregnant or breast-feeding.
• Subject index ulcer associated with carcinoma.
• Subject has active Charcot Neuroarthropathy
• Subject requires extensive soft tissue and bone debridement in the operating room
• Subject has a life expectancy of less than six months as assessed by the investigator.
• Subject not in reasonable metabolic control in the judgment of the investigator
• Subject with a known history of poor compliance with medical treatments
• Subject currently undergoing cancer treatment
• Subject has been on oral steroid use of \<7.5 mg daily for greater than seven consecutive days in 30 days before screening
• Subject is taking parenteral corticosteroids or any cytotoxic agents for seven consecutive days in the period of 30 days before screening
• The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before screening
• Subject has been diagnosed or had medical history with at least one of the following diseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquired immunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stage renal disease.
• Subject currently receiving radiation therapy or chemotherapy.
• Patient currently on dialysis or planning to start dialysis.
• Presence of any condition that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
• Subject is unable to sustain off-loading as defined by the protocol
• Subject index ulcer that cannot be offload by an offloading device
• Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and/or presence of acute cellulitis at the index ulcer
• Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the index ulcer during the study
• Subjects who are permanently non-ambulatory (i.e. wheelchair bound)
• The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner)
• Subject has an allergy to primary or secondary dressing materials used in this trial
• In the opinion of the Investigator the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or subject currently has sepsis, i.e., life threatening organ dysfunction caused by a dysregulated host response to infection