Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer

Sponsor
Nanordica Medical OU
Study ID
NCT06667752
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Advanced Antibacterial Wound Dressing — DEVICE
    For the first 4 weeks, wound dressing will be changed twice weekly. Subsequently, dressing selection and change frequency will be managed by the investigator as part of the standard of care for another 8 weeks.
  • Aquacel Ag+ Extra — DEVICE
    For the first 4 weeks, wound dressing will be changed twice weekly. Subsequently, dressing selection and change frequency will be managed by the investigator as part of the standard of care for another 8 weeks.

Study Details

This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers. At least 170 participants will be randomly allocated to be treated either with AAWD or Aquacel Ag+ Extra wound dressing for a 4-week active phase (intervention) followed by an 8-week standard of care period.

Key Dates

First listed
Oct 31, 2024
Start date
Oct 17, 2024
Status verified
Aug 2025
Primary completion
Oct 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Advanced Antibacterial Wound Dressing
  • Active Comparator: Aquacel Ag+ Extra

Primary Outcome Measure

CWC at 12 weeks [ Time Frame: 12 weeks ]

Central Contacts

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