Efficacy of ProgenaMatrix™ in the Management of DFUs

Status Active, not recruiting

Clinical Trial Summary

This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.

Clinical Trial Description

This is a multicenter data collection and treatment study with weekly updates to include pre and post debridement measurements of wound area, photographs and additional comments of wound appearance, exudate, and patient compliance. ProgenaMatrix™ will be used as the dressing to maintain a moist wound environment post-debridement. ProgenaMatrix™ is US Food and Drug Administration (FDA) cleared for the treatment of diabetic foot ulcers. The standard of care for diabetic foot ulcers (DFU) is removal of non-viable tissue, control of infection, maintain a moist wound environment and off-load the ulcer site. All aspects of this research are within the standard of care practice for the treatment of diabetic foot ulcers. The use of ProgenaMatrix™ instead of a traditional dressing to maintain a moist healing wound environment is the only research intervention. Data on any adverse events related to treatment with ProgenaMatrix™ will be collected for research purposes. The data in this study will be collected from subjects with controlled eligibility. The rationale for this control is to provide a real-world data set on subjects that have had their controllable comorbidities attenuated. This is good clinical practice at advanced wound treatment centers. This data will be statistically evaluated to provide a true closure rate when using ProgenaMatrix™ in a subject where standard of care treatments and assessments are followed. As with any good data set the control of as many variables as possible should provide a more consistent closure rate. This type data is not achievable in an observational study. As the investigators move into randomized controlled trials, the investigators will maintain these criteria as the investigators strive to develop a predictive healing model when all aspects of patient care are considered. This will include which advanced dressing would be best applied to the wound based on patient status using an Artificial Intelligence program under development. The investigators will also be looking at historical data on wound closure rates for traditional dressing as well as other advanced dressings that has been collected with similar eligibility criteria. All data input into our model will be controlled by similar eligibility requirements. This data will also be used as historical control for this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06292026
Study type	Interventional
Source	ProgenaCare Global, LLC
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 14, 2022
Completion date	September 2026

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See also
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