Clinical Research Directory

Inclusion Criteria: * Understands and agrees that the standard treatment protocol will include the application of ProgenaMatrix™ as the standard of care for this project. * Have participated in the informed consent process and signed a data collection and treatment specific informed consent. * Be able and willing to comply with the data collection procedures, data collection visits, dressings, and off-loading. * Have type I or type II diabetes mellitus with an Investigator-confirmed glycosylated hemoglobin (HBA1c) of less than or equal to 11.5% within 3 months prior treatment. * Have at least one DFU Ulcer that has been in existence for a minimum of 4 weeks but no more than 12 months and meets all the following criteria: * Ulcer is partial or full thickness without capsule/tendon/bone exposure. * Ulcer is on the foot or ankle. * Ulcer area is greater than 1 sq. cm. but less than 18 sq. cm. post debridement. (Ulcers larger than 18 sq. cm. can be included with the approval of the Medical Monitor.) * If the subject has more than one ulcer the data collection ulcer will be at the discretion of the Investigator. * There is minimum of 1 cm between the ulcer treated and any other ulcer on the same foot. * Have adequate vascular perfusion of the affected limb as defined by one of the following in order of preference. * Ankle-Brachial index of greater than .65 and less the 1.3 * Toe Pressure of greater than 40 mmHg * TcPO2 of greater than 40 mmHg * Patient had vascular re-perfusion more than 30 days prior to inclusion in the study. Exclusion Criteria: * The study ulcer has unexplored tunneling, undermining, or sinus tracts. * The patient is unable to safely ambulate with appropriate off-loading device. * The patient has a known sensitivity to the suggested dressings. * The patient has or is suspected of having gangrene, wound infection, necrosis, redness, pain, purulent drainage or is being treated by antibiotic for the treatment of the above. * The patient has confirmed osteomyelitis of the foot with the ulcer. * The patient is on steroid therapy, immunosuppressive or autoimmune therapy, radiation therapy of the foot, thrombosis. * History of bone of metastatic disease of the affected limb, radiation therapy or chemotherapy within 12 months prior to treatment. * Pregnancy * The patient is affected by any disease other than diabetes that can impair wound healing in the opinion of the Investigator. * The patient has unstable Charcot with bony prominence that will inhibit wound healing. * Excessive lymphedema that will inhibit off-loading. * Is unwilling to allow the use ProgenaMatrix™ as the standard of care for this data collection project.