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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Penn North Centers for advance wound care
Eire, Pennsylvania, United States
RECRUITINGDiabetes Klinik Bad Mergentheim Gmbh&CO. KG
Bad Mergentheim, Germany
RECRUITINGUniversity of Pisa
Pisa, Italy
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 diabetic foot ulcers ulcers will be defined as the proportion of wounds which reach a minimum 50% percentage reduction in wound surface area over a four-week treatment period.
Time frame: 4 weeks
Reduction in wound area and cost effectiveness
The relative reductions in wound surface area from baseline over twelve weeks of treatment.
Time frame: 12 weeks
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Clinica Universitaria de Podologia
Madrid, Spain, Spain
RECRUITINGBradford Royal Infirmary
Bradford, Yorkshire, United Kingdom
RECRUITING