Performance of WOUNDCHEK Bacterial Status

Part of paid clinical trials in Lake Success, New York.

Sponsor
Woundchek Laboratories BV
Study ID
NCT06501105
Status
Recruiting
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Conditions

  • Wound Heal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • WOUNDCHEK Bacterial Status — DEVICE
    Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid.

Study Details

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.

Key Dates

Start date
Jun 18, 2024
Status verified
Jul 2024
Primary completion
Oct 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: WOUNDCHEK Bacterial Status positive
    Wounds positive for bacterial protease activity that may delay healing if untreated. Pre- and post-test treatment plan recorded.
  • Arm: WOUNDCHEK Bacterial Status negative
    Wounds negative for bacterial protease activity. Pre- and post-test treatment plan recorded.

Primary Outcome Measure

Healing rate and mean percent wound area reduction [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health Comprehensive Wound Healing & Hyperbaric CenterLake SuccessNew York11042
Alisha Oropallo, MD
[email protected]
516-233-3780

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By research site
Northwell Health Comprehensive Wound Healing & Hyperbaric Center· Lake Success, NY

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