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

Launched by NANORDICA MEDICAL OU · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new type of wound dressing called Nanordica Advanced Antibacterial Wound Dressing (AAWD) for people with diabetic foot ulcers. Diabetic foot ulcers are sores that can develop on the feet of individuals with diabetes, and they can sometimes become infected. In this study, at least 170 participants will be randomly assigned to receive either the AAWD or a different wound dressing for four weeks. After that, everyone will receive standard care for their wounds for another eight weeks.

To participate in this trial, individuals must be at least 18 years old and have had a diabetic foot ulcer for over four weeks, with certain conditions regarding the size and infection level of the wound. It's important that participants are willing to follow the study procedures, which include scheduled visits and tests. However, there are some restrictions, such as not having certain serious health issues or recent treatments on the same leg as the ulcer. Participants can expect regular check-ups to monitor their healing process and to see how well the new dressing works compared to the standard one.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntary, written informed consent obtained prior to any study related activities.
• • Males and females aged ≥18 years.
• • Patients suffering DFUs for more than 4 weeks with a maximum diameter of 4 cm.
• • Wound infection grades 1 (absent) or 2.
• • Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures.
• Exclusion Criteria:
• • Patients receiving systemic or topical antibiotic therapy within 7 days before the enrolment.
• • Patients with any wound with known associated osteomyelitis or positive probe-to-bone test.
• • Patients who have previously been randomized in this clinical trial.
• • Patients who have undergone surgical procedures (e.g., radical debridement, ulcerectomy, surgical offloading, revascularization) or other advanced therapies (e.g. skin substitutes, negative pressure therapy, hyperbaric oxygen therapy) in the same leg than the index wound(s) (i.e., the ones treated and evaluated during the study) within the past four weeks, or are planned to undertake such procedures.
• • Patients suffering cardiac disorders grade NYHA IV.
• • Patients suffering hepatic disorders grade Child-Pugh C.
• • Patients suffering advanced (stage 4) cancer.
• • Patients with ankle-brachial pressure index ≤0.8 or limb peripheral arterial pressure \<60 mmHg.
• • Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.