Clinical trial NCT06667752: Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetic Foot Infection
Keywords: DFU
Diabetic foot ulcer
Diabetic foot infection
Chronic ulcer
Lead sponsor: Nanordica Medical OU
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: CWC at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: CWC at 4 weeks
timeFrame: 4 weeks
measure: Time to heal
timeFrame: Up to 12 weeks
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Arcos de la Frontera
country: Spain
facility: Centro de Salud de Arcos de la Frontera
state: Cádiz
city: Jerez de la Frontera
country: Spain
facility: Centro de Salud San Benito
state: Cádiz
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: León
country: Spain
facility: Hospital de León
city: Madrid
country: Spain
facility: Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Study officials:
References: