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Tests treatment safety and results for Diabetic Foot Ulcer
Official title Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
ClinicalTrials.gov ID: NCT06667752
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Use of other advanced therapies directly involving the index ulcer(s) (e.g. skin substitutes, matrices, cellbased therapies or products) within the...
- Patients suffering cardiac disorders grade NYHA IV.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tallinn, Harju, Estonia
- Tartu, Tartu, Estonia
- Arcos de la Frontera, Cádiz, Spain
- Cadiz, Cádiz, Spain
- Jerez de la Frontera, Cádiz, Spain
- León, León, Spain
- Madrid, Madrid, Spain
- Madrid, Spain
- San Sebastián, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tallinn, Harju, Estonia; Tartu, Tartu, Estonia; Arcos de la Frontera, Cádiz, Spain; Cadiz, Cádiz, Spain; Jerez de la Frontera, Cádiz, Spain; León, León, Spain and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.