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临床试验/NCT07758855
NCT07758855已完成不适用

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

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2024年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
1
主要终点
Change in wound surface area

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Nanotechnological silver-coated wound dressing (Device)

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.

干预措施: Sterile saline-moistened gauze dressing (Other)

结局指标

主要结局

Change in wound surface area

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serap Ulusoy

General Surgeon

Ankara City Hospital Bilkent

研究点 (1)

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