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

NCT06667752 | Active Not Recruiting

• 2 other identifiers: NM2023CIV-ES-24-10-049337
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 8

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 136 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.

Conditions

Diabetic Foot Ulcer; Diabetic Foot Infection

Keywords

DFU; Diabetic foot ulcer; Diabetic foot infection; Chronic ulcer

Outcome Measures

Primary Outcomes (1)

• Composite Wound Healing Response at 12 weeks

  Composite Wound Healing Response (CWHR) defined as either a wound area reduction (WAR) of more than 50% at 4 weeks relative to baseline (WAR50/4) and/or complete wound closure (CWC) at 12 weeks (CWC/12)

  12 weeks

Secondary Outcomes (1)

• Wound area reduction at 4 weeks

  4 weeks

Other Outcomes (2)

• Adverse events

  12 weeks

• CWC at 12 weeks

  12 weeks

Study Arms (2)

Advanced Antibacterial Wound Dressing

EXPERIMENTAL

Device: Advanced Antibacterial Wound Dressing

Aquacel Ag+ Extra

ACTIVE COMPARATOR

Device: Aquacel Ag+ Extra

Interventions

Advanced Antibacterial Wound Dressing DEVICE

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.

Advanced Antibacterial Wound Dressing

Aquacel Ag+ Extra DEVICE

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.

Aquacel Ag+ Extra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• Ankle-brachial index (ABI) 0.9-1.4 or ABI between 0.6-0.9 with ankle pressure ≥ 70 mmHg.

You may not qualify 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 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.

Sponsors & Collaborators

• Nanordica Medical OU: lead

Study Sites (11)

East Tallinn Central Hospital

Tallinn, Harju, Estonia

Location

North Estonia Medical Centre Foundation

Tallinn, Harju, Estonia

Location

Tartu University Hospital

Tartu, Tartu, Estonia

Location

Centro de Salud de Arcos de la Frontera

Arcos de la Frontera, Cádiz, Spain

Location

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

Location

Centro de Salud San Benito

Jerez de la Frontera, Cádiz, Spain

Location

Hospital de León

León, León, Spain

Location

Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Madrid, Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Fundación Alcorcón

Madrid, Spain

Location

Hospital Universitario de Donostia

San Sebastián, Spain

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

ES (8)