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

ConditionsDiabetic Foot UlcerDiabetic Foot Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanordica Medical OU

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary, written informed consent obtained prior to any study related activities.

Males and females aged ≥18 years.

DFU(s) present for more than 4 weeks with a maximum diameter of 4 cm.

IWGDF/IDSA Wound infection grades 1 (absent) or 2.

Disqualifiers

Ssystemic or topical antibiotic therapy within 7 days before the enrolment.

Any wound with known associated osteomyelitis or positive probe-to-bone test.

Previous randomization in this clinical trial.

Surgical procedures in the same leg as the index ulcer(s) (e.g., radical debridement, ulcerectomy, skin grafting, exostectomy, amputation) within the past four weeks, or planned to during the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Advanced Antibacterial Wound DressingExperimental treatment 1 intervention
Group B: Aquacel Ag+ ExtraActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

CWC at 12 weeks

complete wound closure (CWC) at 12 weeks

Time frame
12 weeks

Secondary outcomes

1

CWC at 4 weeks

complete wound closure (CWC) at 4 weeks

Time frame
4 weeks
2

Time to heal

Time until complete wound closure.

Time frame
Up to 12 weeks
3

Adverse events

Number and severity of adverse events

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanordica Medical OU

Lead sponsor

Source ClinicalTrials.gov
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