Diabetic Foot UlcerNM2023NCT06667752
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
A study testing Advanced Antibacterial Wound Dressing and Aquacel Ag+ Extra in people with Diabetic Foot Ulcer and Diabetic Foot Infection, run by Nanordica Medical OU at 11 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot Infection
- What is being tested?
- Advanced Antibacterial Wound Dressing and Aquacel Ag+ Extra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 17 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Spain8 sites
Centro de Salud de Arcos de la Frontera
Arcos de la Frontera, Cádiz
Hospital Puerta del Mar
Cadiz, Cádiz
Centro de Salud San Benito
Jerez de la Frontera, Cádiz
Hospital de León
León, León
Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Madrid, Madrid
Hospital Ramón y Cajal
Madrid
Hospital Universitario Fundación Alcorcón
Madrid
Hospital Universitario de Donostia
San Sebastián
Estonia3 sites
East Tallinn Central Hospital
Tallinn, Harju
North Estonia Medical Centre Foundation
Tallinn, Harju
Tartu University Hospital
Tartu, Tartu
About this study
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
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
- Being tested
- Advanced Antibacterial Wound Dressing, Aquacel Ag+ Extra
- Keywords
- DFU, Diabetic foot ulcer, Diabetic foot infection, Chronic ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Antibacterial Wound Dressing | Experimental | Not described Receives: Device: Advanced Antibacterial Wound Dressing |
| Aquacel Ag+ Extra | Active comparator | Not described Receives: Device: Aquacel Ag+ Extra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (1)
Wound area reduction at 4 weeks
Wound area reduction at 4 weeks expressed as percent change from baseline measured using the transparent film method
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start17 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanordica Medical OU
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667752
- Sponsor's protocol ID
- NM2023
- Other IDs
- CIV-ES-24-10-049337
- Acronym
- NM2023
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06667752
- Acronym / sponsor ID
- NM2023 / NM2023
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot Infection
- Keywords
- DFU, Diabetic foot ulcer, Diabetic foot infection, Chronic ulcer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Nanordica Medical OUIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Antibacterial Wound Dressing | Experimental | Device: Advanced Antibacterial Wound Dressing |
| Aquacel Ag+ Extra | Active comparator | Device: Aquacel Ag+ Extra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Antibacterial Wound DressingFor 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. | Device | Advanced Antibacterial Wound Dressing |
| Aquacel Ag+ ExtraFor 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. | Device | Aquacel Ag+ Extra |
Primary outcome
Composite Wound Healing Response at 12 weeks
Time frame: 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)
1 secondary outcome
Wound area reduction at 4 weeks
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Antibacterial Wound Dressing and Aquacel Ag+ Extra in people with Diabetic Foot Ulcer and Diabetic Foot Infection, run by Nanordica Medical OU at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Wound Healing Response at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.