Diabetes Foot Care Clinical Pathway Project - Exciton Technologies Inc
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Infection assessed as per Infectious Disease Society of America (IDSA) guidelines
研究概览
简要总结
In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care as 1 of 3 significant targets for pan-provincial action. Of 210,000 people with diabetes in Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were 425 lower limb amputations (LLA). Moreover, there is a tremendous reduction in quality of life of the patients and attendant negative effects on their families. The 5-year mortality rate after new-onset diabetic foot ulcer is 43-55% and as high as 74% for patients undergoing LLA (CIHI, 2013). The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment of foot ulcers in an effort to reduce LLA by 50% by implementing High Risk Foot Teams (HRFTs) across the province starting with 3 Pilot sites. Existing staff with expertise and knowledge in diabetic foot care will assess and treat patients with moderate and high-risk findings.
In conjunction with the DFCCPP, the efficacy of a technological advancement developed by an Alberta-based small-to-medium enterprise (SME) to improve diabetic foot outcomes will be evaluated. Exsalt® SD7 Wound Dressings (Exciton Technologies, Edmonton, AB) have been demonstrated in-vitro and in-vivo to provide rapid and effective antibacterial activity in an easy-to-use format, thus creating an enhanced wound healing environment while supporting patient quality of life.
The objective of the proposed work is twofold, namely 1) to quantify clinical efficacy of exsalt® Wound Dressings on locally infected diabetic foot ulcers not progressing to healing under the current standard of care: evaluating key indicators of infection, Infectious Diseases Society of America (IDSA) wound classification, and wound size; identifying benefits to foot ulcer healing and 2) to evaluate subjective patient outcomes: satisfaction, perceived benefit, compliance. Evaluating the benefits of utilization of the Exciton exsalt® Wound Dressings when combined with the DFCCP.
详细描述
2 Background Information
2.1 Device Description
Exsalt® Wound Dressings (Test Dressings) contain oxidized silver oxysalts deposited throughout a non-woven polyester/High density polyethylene non-adherent dressing. Silver in the exsalt® Wound Dressings inhibits microbial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm2 (2.5% w/w). The exsalt® dressings have been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis. Exsalt® Wound Dressings maintain their antibacterial activity for up to 7 days against Pseudomonas aeruginosa and Staphylococcus aureus.
Exsalt® Wound Dressings are indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
2.2 Study History
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosed with diabetes mellitus according to definitions outlined by the American Diabetes Association
- •Presenting with a localized mild infection of the ulcer as listed in the IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (Table 1); exceeding 0.5 cm2 in area after appropriate debridement
- •Diagnosis of mild infection must be confirmed immediately following debridement at Baseline
- •Subject must agree to adhere to all protocol procedures and must be willing and able to provide written informed consent.
- •Correction or optimization of underlying medical problems (e.g. diabetes or systemic infection).
- •Wound has been identified as stalled or persistent non-healing under current standard-of-care; showing no progression in 2 weeks as per IDSA guidelines
排除标准
- •Use of systemic antibiotics within the previous 2 weeks
- •Known silver sensitivity
- •Current use of enzymatic debridement
- •Wounds where best practice wound bed preparation is not available or applicable (eg, wound with diminutive oxygen supply would be contraindicated for debridement.
- •No palpable dorsalis pedis or posterior tibial pulse or a pedal systolic pressure (Doppler) of ≤ 40 mm Hg
- •Evidence of systemic infection (fever, chills, hypotension)/sepsis
- •Non-study systemic or anti-infective topical agents
研究组 & 干预措施
Exciton
Treatment of diabetic foot ulcer with Exciton Exsalt wound dressing
干预措施: Exciton (Device)
结局指标
主要结局
Infection assessed as per Infectious Disease Society of America (IDSA) guidelines
时间窗: 28 days
Assessed as per Infectious Disease Society of America (IDSA) guidelines
次要结局
- Pain assessed with Ordinal scale(28 days)
- Wound volume(28 days)
- Safety and complications (incidence of adverse events)(28 days)
研究者
Catherine Chan
Professor
University of Alberta