ProgenaMatrix Keratin graft: place ProgenaMatrix graft on the wound
standard of care: apply non adherent dressing
Study summary
This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
time to wound closure — 12 weeks of treatment The endpoint of this data collection process is to study the timepoint for total wound closure following the protocol procedures in the use of ProgenaMatrix™.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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