Actively Recruiting
Performance of WOUNDCHEK Bacterial Status
Led by Woundchek Laboratories BV · Updated on 2024-07-15
75
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
Sponsors
W
Woundchek Laboratories BV
Lead Sponsor
N
Northwell Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) when the test result is used to inform treatment decisions.
CONDITIONS
Official Title
Performance of WOUNDCHEK Bacterial Status
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has a venous leg ulcer, diabetic foot ulcer, or pressure ulcer suspected not to be infected, showing no more than two of the NERDS signs of infection
- Subject is 18 years of age or older
- Wound is between 21 days and 6 months old, or older than 6 months if less than 1 cm squared in area
- Subject agrees to complete all study procedures and provides written informed consent per IRB requirements
You will not qualify if you...
- Subject does not meet inclusion criteria
- Target wound contains a malignancy
- Subject has hypersensitivity or painful wound surface preventing touching or swabbing
- Subject is confirmed positive for HIV or hepatitis
- Subject is unable or unwilling to provide informed consent
- A designated wound area may only be enrolled once; re-opened healed wounds cannot be re-enrolled
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwell Health Comprehensive Wound Healing & Hyperbaric Center
Lake Success, New York, United States, 11042
Actively Recruiting
Research Team
J
Jack Wilkens, MBA
CONTACT
S
Simon W Bayliff, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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