Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
A Randomized, Double Blind, Active Controlled, Parallel Group Clinical Trial to Assess the Safety and Efficacy of Nanordica Antibacterial Wound Dressing in Patients With DFUs
Nanordica Medical OU
170 participants
Oct 17, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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.
- Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures.
- Ankle-brachial index (ABI) 0.9-1.4 or ABI between 0.6-0.9 with ankle pressure ≥ 70 mmHg.
Exclusion Criteria9
- 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.
- Use of other advanced therapies directly involving the index ulcer(s) (e.g. skin substitutes, matrices, cellbased therapies or products) within the past four weeks.
- Patients suffering cardiac disorders grade NYHA IV.
- Patients suffering hepatic disorders grade Child-Pugh C.
- Stage 4 cancer.
- Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06667752