Nanotechnological Silver-Coated Dressing in Diabetic Foot Ulcers

NCT07758855 | Completed

• 2 other identifiers: SU-13E2-24-6630
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Diabetic Foot; Foot, Diabetic; Foot Ulcer, Diabetic; Feet, Diabetic

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 (baseline), Day 3, Day 7 and Day 21

Secondary Outcomes (2)

• Microbiological findings on deep tissue culture

  Day 0, Day 3, Day 7 and Day 21

• Change in PEDIS grade

  Day 0, Day 3, Day 7 and Day 21

Other Outcomes (1)

• Number of participants with local hypersensitivity or allergic reaction

  From first dressing application through Day 21

Study Arms (2)

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.

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.

Other: Sterile saline-moistened gauze dressing

Interventions

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.

Nanotechnological silver-coated dressing

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.

Also known as: Conventional dressing, wet-to-dry gauze dressing

Conventional saline-moistened gauze dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• ARGEN Medical and Health Products Inc.: collaborator

Study Sites (1)

Ankara Bilkent City Hospital, Department of General Surgery

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 32513260 BACKGROUND

• Sahin 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.

  PMID: 35022147 BACKGROUND

• James 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.

  PMID: 31007506 BACKGROUND

• Lin 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.

  PMID: 34621128 BACKGROUND

• Wang 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.

  PMID: 33916790 BACKGROUND

• Huang 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.

  PMID: 33607864 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: May 6, 2024
• Primary Completion: July 13, 2026
• Study Completion: August 5, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

TU (1)