An Open label, Single arm, Single centered, Pilot clinical study to evaluate the safety and efficacy of nanofibrous bioactive enriched wound dressing product (Smart Dre-M) in subjects with General, Diabetic, and Burn Wounds.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Wound Healing as Assessed by Wound Size Reduction and PUSH Tool
研究概览
简要总结
Brief Summary:
This interventional, open-label clinical study will assess primary outcomes including reduction in wound size and improvement in Pressure Ulcer Scale for Healing (PUSH) scores from Baseline to Day 90. Secondary outcomes include time to complete wound closure using the Bates-Jensen Wound Assessment Tool (BWAT), pain reduction using the Visual Analog Scale (VAS), and overall safety and tolerability by monitoring adverse events and any local or systemic reactions. Assessments will be conducted at Baseline (Day 0), Day 30, Day 60, and Day 90 to monitor wound healing progression.
Purpose of the Study:
The purpose of this study is to evaluate the safety and efficacy of Smart Dre-M, a nanofibrous bioactive wound dressing, in promoting wound healing in participants with chronic wounds. The study aims to determine whether Smart Dre-M can reduce wound size and improve healing scores over a 90-day period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects aged between 18 and 65 years.
- •Presence of general, diabetic, or burn wounds, of duration less than 6 months.
- •Wound size between 1 cm² and 50 cm² and located at accessible body sites for dressing application.
- •Ability and willingness to provide written informed consent.
- •Willingness to comply with study procedures and return for scheduled follow-up visits.
排除标准
- •Participation in another interventional clinical study within the past 30 days.
- •Known or suspected pregnancy or currently breastfeeding.
- •Presence of malignancy, autoimmune skin conditions, or wounds of venous/ischemic origin.
- •History of severe allergy to dressing components (chitosan, gelatin, PVA, herbal extracts, copper).
- •Active local or systemic infection requiring systemic antibiotics at the time of enrollment.
- •Subjects with poor peripheral perfusion or non-palpable distal pulses (for diabetic wounds).
- •Significant comorbidities (e.g., uncontrolled diabetes, renal or hepatic failure) that may interfere with wound healing or data interpretation.
- •Known substance abuse (alcohol, tobacco, or narcotics) that may impair healing or protocol compliance.
- •Inability or unwillingness to provide consent or adhere to study requirements.
结局指标
主要结局
Wound Healing as Assessed by Wound Size Reduction and PUSH Tool
时间窗: Baseline - Day 0 | Day 30 | Day 60 | Day 90
1. Endpoint Description
时间窗: Baseline - Day 0 | Day 30 | Day 60 | Day 90
Measurement Parameters:
时间窗: Baseline - Day 0 | Day 30 | Day 60 | Day 90
a) Wound Size (cm square)
时间窗: Baseline - Day 0 | Day 30 | Day 60 | Day 90
b) PUSH Tool Score
时间窗: Baseline - Day 0 | Day 30 | Day 60 | Day 90
次要结局
- Time to Complete Wound Closure as assessed using Bates-Jensen Wound Assessment Tool (BWAT)(and Serial Digital Photography.)
研究者
Dr Ambanna Gowda
Citizen Hospital, Bangalore