EPC Silver Wound Gel (EPC-123) Feasibility Clinical Study: Prospective, Single-arm, Repeated Measures Study of EPC Silver Wound Gel in the Management of Locally Infected Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incidence of intervention-related adverse events collected throughout the trial
研究概览
简要总结
The objective of this single-arm feasibility study is to investigate the safety and impact of the topical EPC Silver Wound Gel (EPC-123) in the management of diabetic foot ulcer wounds not progressing under the current standard of care.
详细描述
The objective of the proposed work is 1) to monitor clinical safety of EPC Silver Wound Gel on diabetic foot ulcers, 2) to evaluate the clinical impact of EPC Silver Wound Gel in foot ulcer progression in conjunction with the standard of care 3) to quantify the changes within the wound bacterial environment as it impacts wound healing and 4) to evaluate subjective patient and clinician outcomes: satisfaction, quality of life, perceived benefit, and compliance.
Consenting subjects who qualify for enrollment will proceed with two, weekly, visits related to screening. If screen passed, ie. under the current standard of care no progression of the diabetic foot ulcer is observed in accordance with validated diabetic foot ulcer classification metrics, then the subject will proceed with two weeks of study period where twice weekly clinic and twice weekly intermediate home-based care. This may be followed by an additional two weeks of study period, if warranted in accordance with best practice, with once weekly clinic and intermediate home care visits. In total there will be up to 9 clinic visits (minimum 7 clinic visits up to 9 clinic visits) in 6 weeks (screening and trial visits; minimum 4 weeks up to a maximum of 6 weeks).
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
盲法说明
Patients will be assigned an internal ID number
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 an active or current foot ulcer that has been identified as stalled or persistent non-healing under current standard-of-care; showing no progression in 2 weeks as per IDSA guidelines.
- •Presenting with a localized mild or local infection of the ulcer as listed in the IWGDF/IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (Table 1); exceeding 0.5 cm2 in area after appropriate debridement.
- •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).
排除标准
- •Participants exhibiting extensive gangrene, and/or immediately limb-threatening infection
- •Indications of osteomyelitis identified by plain radiographs taken within 2 days prior to study entry.
- •No palpable dorsalis pedis or posterior tibial pulse or a pedal systolic pressure (Doppler ultrasound) of ≤ 40 mm Hg
- •Clinically significant peripheral arterial disease requiring vascular intervention
- •Patients requiring renal dialysis, immunosuppressive mediation, or those with uncontrolled hypertension.
- •Lymphangitis; spread beneath the fascia; muscle, joint, or bone involvement.
- •IDSA-defined severe infection, including systemic toxicity or metabolic instability
- •Current use of enzymatic debridement.
- •Participants with known silver sensitivity
结局指标
主要结局
Incidence of intervention-related adverse events collected throughout the trial
时间窗: Up to 28 days
Clinical and/or biological adverse events will be reported over the intervention period. Severity of any adverse events will be graded.
次要结局
- Qualitative improvement in quality of life assessment during the intervention period compared with screening period under standard of care.(Up to 28 days)
- Early clinical response(Within 48-72 hours of first intervention application)
- Progression the Diabetic Foot Infection (DFI) Wound Score during the intervention period compared with screening period under standard of care.(Up to 42 days)
- Progression the Bioburden Assessment Tool (BAT) during the intervention period compared with screening period under standard of care.(Up to 42 days)
- Progression of the Infectious Diseases Society of America and International Working Group on the Diabetic Foot Classifications of Diabetic Foot Infection during the intervention period compared with screening period under standard of care.(Up to 42 days)
- Progression in the absolute number of critical or qualified pathogen species present within the wound microbiome over the course of the intervention versus screening and baseline.(Up to 42 days)
- Progression of systemic biomarker CBC and Differential.(Up to 28 days)
- Number of participants with systemic antibiotic or antifungal drug administration over the course of the intervention versus screening and baseline.(Up to 42 days)
- Progression in the relative quantity of critical or qualified pathogens versus commensal organisms present within the wound microbiome over the course of the intervention versus screening and baseline.(Up to 42 days)
- Rate of wound closure, specifically percent change in area, during the intervention period compared with screening period under standard of care.(Up to 42 days)
- Qualitative evaluation of patient satisfaction via questionnaire.(Up to 28 days)
- Progression of systemic biomarker C-Reactive protein (CRP).(Up to 28 days)
- Progression in wound microbiome over the course of the intervention versus screening and baseline.(Up to 42 days)
- Percent change in wound area and volume during the intervention period compared to baseline.(Up to 28 days)
- Qualitative evaluation of clinician satisfaction via questionnaire.(Up to 28 days)
- Progression of systemic biomarker Erythrocyte sedimentation rate (ESR).(Up to 28 days)
- Progression in peri-wound microbiome over the course of the intervention versus screening and baseline.(Up to 42 days)
- Rate of wound closure, specifically percent change in volume, during the intervention period compared with screening period under standard of care.(Up to 42 days)
- Quantitative progression of local inflammatory biomarkers over the course of the intervention versus screening and baseline.(Up to 42 days)
- Progression of systemic biomarker body temperature.(Up to 42 days)