Efficacy of ProgenaMatrix™ in the Management of DFUs (NCT06292026) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy of ProgenaMatrix™ in the Management of DFUs
United States100 participantsStarted 2022-03-14
Plain-language summary
This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.
Who can participate
Age range18 Years – 85 Years
SexALL
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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 vascu…