Irrisept™ irrigation containing Chlorhexidine Gluconate (CHG) 0.05% in sterile water, is an irrigation method that may help reduce bacterial load considerably more than traditional saline irrigation.
The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™ irrigation. This is a jet irrigation of 0.05% Chlorhexidine Gluconate (CHG) in sterile water delivered under pressure by manual compression of the bottle by the user. This treatment allows for management of bioburden in a wound through broad spectrum antimicrobial activity by the CHG as well as removal of debris from the wound bed. In this trial, participants with partial and full thickness diabetic foot ulcers (DFUs) - 'full skin thickness and extending through the subcutaneous or fat layers or to deeper structures such as tendon and fascia will receive standard of care treatment with indicated off-loading device (SOC) for their condition in addition to wound bed irrigation with Irrisept™ or saline Irrigation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Northern Illinois Foot & Ankle Specialists
Cary, Illinois, United States
Northern Illinois Foot & Ankle Specialists
Crystal Lake, Illinois, United States
Northern Illinois Foot & Ankle Specialists
Elgin, Illinois, United States
Northern Illinois Foot & Ankle Specialists
Fox Lake, Illinois, United States
The primary endpoint is the percentage of index ulcers healed at 12 weeks
Percentage of index ulcers healed from baseline up to 12 weeks
Time frame: Weekly up to 12 weeks
Time: to heal within 12 weeks
Days to heal from baseline up to 12 weeks
Time frame: Weekly up to 12 weeks
Percent Area Reduction (PAR) at 12 weeks
Percent Area Reduction (PAR) from baseline up to 12 weeks
Time frame: Weekly up to 12 weeks
Pain reduction between visits, measured by Visual Analogue Scale (VAS)
Pain reduction from baseline up to 12 weeks. VAS (0-100 scale; 0 being no discomfort, 100 being intense discomfort)
Time frame: Weekly up to 12 weeks
Wound complication rate
Infection, return to operating room for management or other adverse events during the treatment course.
Time frame: Weekly up to 12 weeks
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Northern Illinois Foot & Ankle Specialist
Lake in the Hills, Illinois, United States