Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer (NM2023)

Nanordica Medical OU

Status

Enrolling

Conditions

Diabetic Foot Infection

Diabetic Foot Ulcer

Treatments

Device: Aquacel Ag+ Extra

Device: Advanced Antibacterial Wound Dressing

Study type

Interventional

Funder types

Industry

Identifiers

NCT06667752

NM2023

CIV-ES-24-10-049337 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.