The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes. Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds
The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes. It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care. Wounds with EPA will be determined using a new POC diagnostic test, WOUNDCHEK™ Protease Status, and the efficacy of PROMOGRAN®, a protease modulating therapy will be determined against standard of care (moist wound healing and compression) in VLU wounds in both elevated EPA and low protease activity wounds.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
250
Promogran is a collagen/ORC dressing which modulates the wound environment
Compression bandage
Penn North Centers for Advance Wound Care
Eire, Pennsylvania, United States
RECRUITINGUniversity Medical Center Gieben and Marburg GmBH
Marburg, Germany
RECRUITINGDres. Bolko Alter Siamak Pourhassan
Oberhausen, Germany
The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test
The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test, and to compare the healing outcomes of two treatment regimes (PROMOGRAN®, a protease modulating therapy and current standard of care) on chronic wounds with EPA. An improved healing outcome for venous leg ulcers will be defined as the proportion of wounds which reach a minimum 30% percentage reduction in wound surface area over a four-week treatment period.
Time frame: 12 weeks
The average percentage change in protease activity levels pre and post treatment
The proportion of wounds achieving wound closure (defined as a restoration of a complete epithelial cover) at twelve weeks and the average time to wound closure. The relative cost effectiveness of both treatment regimes when they are targeted appropriately; PROMOGRAN®, a protease modulating therapy targeted to wounds with EPA and standard of care to wounds with LPA.Healing outcomes for standard of care on EPA wounds as compared to LPA wounds. Healing outcomes for PROMOGRAN®, a protease modulating therapy on EPA wounds as compared to LPA wounds.
Time frame: 12 weeks
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University of Pisa
Pisa, Roma, Italy
RECRUITINGUniversity of Ferrara
Ferrara, Italy
RECRUITINGCardiff University
Cardiff, Wales, United Kingdom
RECRUITINGBradford Royal Infirmary
Bradford, Yorkshire, United Kingdom
RECRUITING