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Completed

NCT Number: NCT07758855

Nanotechnological Silver-Coated Dressing in Diabetic Foot Ulcers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital, Department of General Surgery

Ankara, Cankaya, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nanotechnological silver-coated wound dressing

Device

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 dressing

Other

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.

Other names: Conventional dressing, wet-to-dry gauze dressing

Primary outcomes

  1. 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.

Secondary outcomes

  1. Microbiological findings on deep tissue culture

    Time frame: Day 0, Day 3, Day 7 and Day 21

    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.

  2. Change in PEDIS grade

    Time frame: Day 0, Day 3, Day 7 and Day 21

    Wound staging is performed with the PEDIS classification and change in grade is compared between the two groups.

Other outcomes

  1. Number of participants with local hypersensitivity or allergic reaction

    Time frame: From first dressing application through Day 21

    Local hypersensitivity and local or systemic allergic reactions attributable to the silver-containing dressing are recorded as adverse events.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Collaborators

  • ARGEN Medical and Health Products Inc.

Registry information

Official study title

Effects of the Lunwell® Nanotechnology-Based Silver Dressing on Infected Diabetic Foot Wounds: A Prospective Controlled Study

Acronym: NANOSIL-DFU

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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