Diabetic Ulcers on Both FeetNANOSIL-DFUNCT07758855
Nanotechnological Silver-Coated Dressing in Diabetic Foot Ulcers
A study testing Nanotechnological silver-coated wound dressing and Sterile saline-moistened gauze dressing in people with Diabetic Ulcers on Both Feet, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Diabetic foot ulcers are the complication of diabetes most frequently requiring hospitalization and carry very high treatment costs. Ulcers that fail to heal may lead to amputation of the foot or leg, causing permanent disability and major loss of working capacity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ulcers on Both Feet
- What is being tested?
- Nanotechnological silver-coated wound dressing and Sterile saline-moistened gauze dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2024to 5 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aged over 18 years
- Able and willing to give written informed consent
- PEDIS grade 2 or PEDIS grade 3 diabetic foot ulcer on either foot
Who cannot join
- Aged under 18 years
- Known allergy to silver or to polyester
- Pregnancy
- Non-infected PEDIS grade 1 ulcer
- PEDIS grade 4 ulcer, on the grounds of metabolic instability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital, Department of General Surgery
Ankara, Cankaya, 06800
About this study
Official title: Effects of the Lunwell® Nanotechnology-Based Silver Dressing on Infected Diabetic Foot Wounds: A Prospective Controlled Study
Diabetic foot ulcers are the complication of diabetes most frequently requiring hospitalization and carry very high treatment costs. Ulcers that fail to heal may lead to amputation of the foot or leg, causing permanent disability and major loss of working capacity. Neuropathy, vasculopathy and infection are the principal drivers of ulcer formation, and the bacteria encountered in these ulcers frequently show high antibiotic resistance. Locally acting wound care products are therefore of considerable importance.
Silver has been used in wound treatment since antiquity. Silver nanoparticles have broad antibacterial, antifungal and antiviral properties: they can penetrate bacterial cell walls, alter membrane structure, increase membrane permeability, generate reactive oxygen species and release silver ions that inhibit deoxyribonucleic acid replication, and may result in cell death. Nanotechnologically produced silver products are thought to achieve greater tissue penetration and anti-infective activity, which is also relevant to the biofilm layer formed by bacteria, a recognised barrier to healing that is highly resistant to conventional antimicrobial therapy.
This study evaluates the effects of a nanotechnologically produced, Turkish-manufactured silver-coated wound care dressing in diabetic foot ulcers, compared with conventional dressing using sterile saline-moistened gauze. Participants with a PEDIS grade 2 or grade 3 diabetic foot ulcer are allocated to the investigational dressing or to the conventional dressing. All participants receive routine diabetic foot care in addition to the assigned dressing. Wounds are assessed on days 0, 3, 7 and 21 by wound measurement, deep tissue culture and histopathological examination of tissue obtained at debridement.
- Conditions
- Diabetic Ulcers on Both Feet
- Being tested
- Nanotechnological silver-coated wound dressing, Sterile saline-moistened gauze dressing
- Keywords
- Diabetic Foot, Foot, Diabetic, Foot Ulcer, Diabetic, Feet, Diabetic
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanotechnological silver-coated wound dressingDevice
Sterile, single-layer, non-adherent, flexible, silver-coated polyester dressing for topical use. Silver release over 7 days: 1 ppm. Silver content on the product: 160 mg/100 cm². May remain on the wound for up to 7 days and may be changed more frequently if required; in this study it is changed at 3-day intervals and applied for a total of 21 days.
Sterile saline-moistened gauze dressingOther
Also called Conventional dressing, wet-to-dry gauze dressing
Conventional wound treatment method described in the literature: sterile gauze impregnated with sterile physiological saline, changed daily and applied for a total of 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Nanotechnological silver-coated dressing | Experimental | Routine diabetic foot care plus a topical, sterile, single-layer, non-adherent, flexible, silver-coated polyester dressing. The dressing is changed every 3 days and applied for 21 days. Receives: Device: Nanotechnological silver-coated wound dressing |
| Conventional saline-moistened gauze dressing | Active comparator | Routine diabetic foot care plus conventional wound treatment with sterile gauze impregnated with sterile physiological saline. The dressing is changed daily and applied for 21 days. Receives: Other: Sterile saline-moistened gauze dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound surface area
Wound dimensions are measured at each assessment visit and wound surface area (cm²) is derived. The change from baseline and the time to wound closure are compared between the investigational dressing group and the control group.
Measured: Day 0 (baseline), Day 3, Day 7 and Day 21
Secondary outcomes (2)
Microbiological findings on deep tissue culture
Deep tissue culture is obtained after debridement at each assessment. Culture positivity and identified organisms are compared between the two groups as a measure of local infection control.
Measured: Day 0, Day 3, Day 7 and Day 21
Change in PEDIS grade
Wound staging is performed with the PEDIS classification and change in grade is compared between the two groups.
Measured: Day 0, Day 3, Day 7 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start6 May 2024
- Primary completion13 Jul 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Ulcers on Both FeetStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Model description
- Two parallel groups. Participants with a PEDIS grade 2 or grade 3 diabetic foot ulcer are assigned either to the investigational silver-coated dressing group or to the conventional saline-moistened gauze dressing group. All participants receive routine diabetic foot care in both groups.
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- ARGEN Medical and Health Products Inc.
- Responsible party
- Principal investigator, Serap Ulusoy, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758855
- Sponsor's protocol ID
- SU-13
- Other IDs
- E2-24-6630
- Acronym
- NANOSIL-DFU
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Comino-Sanz IM, Lopez-Franco MD, Castro B, Pancorbo-Hidalgo PL. Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial. Trials. 2020 Jun 8;21(1):505. doi: 10.1186/s13063-020-04445-5.
PubMed 32513260Sahin E, Rizalar S, Ozker E. Effectiveness of negative-pressure wound therapy compared to wet-dry dressing in pressure injuries. J Tissue Viability. 2022 Feb;31(1):164-172. doi: 10.1016/j.jtv.2021.12.007. Epub 2022 Jan 3.
PubMed 35022147James SMD, Sureshkumar S, Elamurugan TP, Debasis N, Vijayakumar C, Palanivel C. Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial. Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18.
PubMed 31007506Lin H, BoLatai A, Wu N. Application Progress of Nano Silver Dressing in the Treatment of Diabetic Foot. Diabetes Metab Syndr Obes. 2021 Oct 1;14:4145-4154. doi: 10.2147/DMSO.S330322. eCollection 2021.
PubMed 34621128Wang YC, Lee HC, Chen CL, Kuo MC, Ramachandran S, Chen RF, Kuo YR. The Effects of Silver-Releasing Foam Dressings on Diabetic Foot Ulcer Healing. J Clin Med. 2021 Apr 3;10(7):1495. doi: 10.3390/jcm10071495.
PubMed 33916790Huang C, Wang R, Yan Z. Silver dressing in the treatment of diabetic foot: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021 Feb 19;100(7):e24876. doi: 10.1097/MD.0000000000024876.
PubMed 33607864
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Lunwell® Nanotechnology-Based Silver Dressing on Infected Diabetic Foot Wounds: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT07758855
- Acronym / sponsor ID
- NANOSIL-DFU / SU-13
- Conditions
- Diabetic Ulcers on Both Feet
- Keywords
- Diabetic Foot, Foot, Diabetic, Foot Ulcer, Diabetic, Feet, Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- ARGEN Medical and Health Products Inc.
- Study start
- 6 May 2024 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 11 Aug 2026 (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.
Diabetic foot ulcers are the complication of diabetes most frequently requiring hospitalization and carry very high treatment costs. Ulcers that fail to heal may lead to amputation of the foot or leg, causing permanent disability and major loss of working capacity. Neuropathy, vasculopathy and infection are the principal drivers of ulcer formation, and the bacteria encountered in these ulcers frequently show high antibiotic resistance. Locally acting wound care products are therefore of considerable importance.
Silver has been used in wound treatment since antiquity. Silver nanoparticles have broad antibacterial, antifungal and antiviral properties: they can penetrate bacterial cell walls, alter membrane structure, increase membrane permeability, generate reactive oxygen species and release silver ions that inhibit deoxyribonucleic acid replication, and may result in cell death. Nanotechnologically produced silver products are thought to achieve greater tissue penetration and anti-infective activity, which is also relevant to the biofilm layer formed by bacteria, a recognised barrier to healing that is highly resistant to conventional antimicrobial therapy.
This study evaluates the effects of a nanotechnologically produced, Turkish-manufactured silver-coated wound care dressing in diabetic foot ulcers, compared with conventional dressing using sterile saline-moistened gauze. Participants with a PEDIS grade 2 or grade 3 diabetic foot ulcer are allocated to the investigational dressing or to the conventional dressing. All participants receive routine diabetic foot care in addition to the assigned dressing. Wounds are assessed on days 0, 3, 7 and 21 by wound measurement, deep tissue culture and histopathological examination of tissue obtained at debridement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups. Participants with a PEDIS grade 2 or grade 3 diabetic foot ulcer are assigned either to the investigational silver-coated dressing group or to the conventional saline-moistened gauze dressing group. All participants receive routine diabetic foot care in both groups.
| Arm | Type | Receives |
|---|---|---|
| Nanotechnological silver-coated dressing | Experimental | Device: Nanotechnological silver-coated wound dressingRoutine diabetic foot care plus a topical, sterile, single-layer, non-adherent, flexible, silver-coated polyester dressing. The dressing is changed every 3 days and applied for 21 days. |
| Conventional saline-moistened gauze dressing | Active comparator | Other: Sterile saline-moistened gauze dressingRoutine diabetic foot care plus conventional wound treatment with sterile gauze impregnated with sterile physiological saline. The dressing is changed daily and applied for 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 18 years
- Able and willing to give written informed consent
- PEDIS grade 2 or PEDIS grade 3 diabetic foot ulcer on either foot
Key exclusion criteria (5 listed)
- Aged under 18 years
- Known allergy to silver or to polyester
- Pregnancy
- Non-infected PEDIS grade 1 ulcer
- PEDIS grade 4 ulcer, on the grounds of metabolic instability
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 |
|---|---|---|
| Nanotechnological silver-coated wound dressingSterile, single-layer, non-adherent, flexible, silver-coated polyester dressing for topical use. Silver release over 7 days: 1 ppm. Silver content on the product: 160 mg/100 cm². May remain on the wound for up to 7 days and may be changed more frequently if required; in this study it is changed at 3-day intervals and applied for a total of 21 days. | Device | Nanotechnological silver-coated dressing |
| Sterile saline-moistened gauze dressingAlso: Conventional dressing, wet-to-dry gauze dressingConventional wound treatment method described in the literature: sterile gauze impregnated with sterile physiological saline, changed daily and applied for a total of 21 days. | Other | Conventional saline-moistened gauze dressing |
Primary outcome
Change in wound surface area
Time frame: Day 0 (baseline), Day 3, Day 7 and Day 21
Wound dimensions are measured at each assessment visit and wound surface area (cm²) is derived. The change from baseline and the time to wound closure are compared between the investigational dressing group and the control group.
2 secondary outcomes
Microbiological findings on deep tissue culture
Time frame: Day 0, Day 3, Day 7 and Day 21
Change in PEDIS grade
Time frame: Day 0, Day 3, Day 7 and Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 32513260Comino-Sanz IM, Lopez-Franco MD, Castro B, Pancorbo-Hidalgo PL. Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial. Trials. 2020 Jun 8;21(1):505. doi: 10.1186/s13063-020-04445-5.
- Background: PubMed 35022147Sahin E, Rizalar S, Ozker E. Effectiveness of negative-pressure wound therapy compared to wet-dry dressing in pressure injuries. J Tissue Viability. 2022 Feb;31(1):164-172. doi: 10.1016/j.jtv.2021.12.007. Epub 2022 Jan 3.
- Background: PubMed 31007506James SMD, Sureshkumar S, Elamurugan TP, Debasis N, Vijayakumar C, Palanivel C. Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial. Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18.
- Background: PubMed 34621128Lin H, BoLatai A, Wu N. Application Progress of Nano Silver Dressing in the Treatment of Diabetic Foot. Diabetes Metab Syndr Obes. 2021 Oct 1;14:4145-4154. doi: 10.2147/DMSO.S330322. eCollection 2021.
- Background: PubMed 33916790Wang YC, Lee HC, Chen CL, Kuo MC, Ramachandran S, Chen RF, Kuo YR. The Effects of Silver-Releasing Foam Dressings on Diabetic Foot Ulcer Healing. J Clin Med. 2021 Apr 3;10(7):1495. doi: 10.3390/jcm10071495.
- Background: PubMed 33607864Huang C, Wang R, Yan Z. Silver dressing in the treatment of diabetic foot: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021 Feb 19;100(7):e24876. doi: 10.1097/MD.0000000000024876.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanotechnological silver-coated wound dressing and Sterile saline-moistened gauze dressing in people with Diabetic Ulcers on Both Feet, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in wound surface area (time frame: Day 0 (baseline), Day 3, Day 7 and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07758855, which also lists 6 linked publications.
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 11 Aug 2026.