NCT06667752

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Oct 2024

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Oct 2024Jun 2026

Study Start

First participant enrolled

October 17, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

October 30, 2024

Last Update Submit

August 26, 2025

Conditions

Diabetic Foot UlcerDiabetic Foot Infection

Keywords

DFUDiabetic foot ulcerDiabetic foot infectionChronic ulcer

Outcome Measures

Primary Outcomes (1)

  • CWC at 12 weeks

    complete wound closure (CWC) at 12 weeks

    12 weeks

Secondary Outcomes (3)

  • CWC at 4 weeks

    4 weeks

  • Time to heal

    Up to 12 weeks

  • Adverse events

    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 DressingDEVICE

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+ ExtraDEVICE

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

East Tallinn Central Hospital

Tallinn, Harju, Estonia

RECRUITING

North Estonia Medical Centre Foundation

Tallinn, Harju, Estonia

RECRUITING

Tartu University Hospital

Tartu, Tartu, Estonia

RECRUITING

Centro de Salud de Arcos de la Frontera

Arcos de la Frontera, Cádiz, Spain

RECRUITING

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

RECRUITING

Centro de Salud San Benito

Jerez de la Frontera, Cádiz, Spain

RECRUITING

Hospital de León

León, León, Spain

RECRUITING

Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Madrid, Madrid, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario Fundación Alcorcón

Madrid, Spain

RECRUITING

Hospital Universitario de Donostia

San Sebastián, Spain

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Central Study Contacts

Grigory Vasiliev

CONTACT

+372 5345 2230grigory@nanordica.com

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

October 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations

ES(8)