Nanotechnological Silver-Coated Dressing in Diabetic Foot Ulcers
Key facts
- Who runs it
- Ankara City Hospital Bilkent
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 107 people enrolled
- Started
- 6 May 2024
- Ended
- 5 Aug 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Nanotechnological silver-coated wound dressing
- Sterile saline-moistened gauze dressing
- Record updated
- 11 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 take part
- Known allergy to silver or to polyester
- Non-infected PEDIS grade 1 ulcer
- PEDIS grade 4 ulcer, on the grounds of metabolic instability
- Aged under 18 years
- Pregnancy
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Nanotechnological silver-coated dressingTreatment being tested
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.
Treatment: Nanotechnological silver-coated wound dressing
- Conventional saline-moistened gauze dressingExisting treatment, for comparison
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.
Treatment: Sterile saline-moistened gauze dressing
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of the Lunwell® Nanotechnology-Based Silver Dressing on Infected Diabetic Foot Wounds: A Prospective Controlled Study
- Record updated
- 11 August 2026