Diabetic Foot Infection, Diabetic Foot Ulcer
Conditions
Keywords
DFU, Diabetic foot ulcer, Diabetic foot infection, Chronic ulcer
Brief 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.
Interventions
DEVICEAdvanced Antibacterial Wound Dressing
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.
DEVICEAquacel Ag+ Extra
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.
Sponsors
Nanordica Medical OU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CWC at 12 weeks | 12 weeks | complete wound closure (CWC) at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CWC at 4 weeks | 4 weeks | complete wound closure (CWC) at 4 weeks |
| Time to heal | Up to 12 weeks | Time until complete wound closure. |
| Adverse events | 12 weeks | Number and severity of adverse events |
Countries
Estonia, Spain
Contacts
Primary ContactGrigory Vasiliev
Outcome results
None listed