Summary:
A Randomized Controlled Clinical Trial Evaluating The Efficacy Of A Borate-Based Bioactive Glass Advanced Wound Matrix And Standard Of Care Versus Standard Of Care Alone
Qualified Participants Must:
• Be at least 18 years of age or older
• Diagnosis of type 1 or 2 Diabetes mellitus
• Have a target diabetic foot ulcer with a minimum surface area of 1.0 sq cm and a maximum surgace area of 20.0 sq cm measured
• Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus
• Target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care
• The target ulcer must be located on the foot with at leaset 50% of the ulcer below the malleolus
• The target ulcer must be full thickness on the foot or ankle that does not probe to bone
• Adequate circulation to the affected foot documented
• If there is more than two ulcers, they must be separated by at least 2 cm
• be offloading
• must agree to attend the weekly study visits required by protocol
• Be willing and able to partiipate in the informed consent process