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.
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Neurop Pharma Products Pvt Ltd.
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Wound Healing as Assessed by Wound Size Reduction and PUSH Tool
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Wound Healing as Assessed by Wound Size Reduction and PUSH Tool
Time Frame: Baseline - Day 0 | Day 30 | Day 60 | Day 90
1. Endpoint Description
Time Frame: Baseline - Day 0 | Day 30 | Day 60 | Day 90
Measurement Parameters:
Time Frame: Baseline - Day 0 | Day 30 | Day 60 | Day 90
a) Wound Size (cm square)
Time Frame: Baseline - Day 0 | Day 30 | Day 60 | Day 90
b) PUSH Tool Score
Time Frame: Baseline - Day 0 | Day 30 | Day 60 | Day 90
Secondary Outcomes
- Time to Complete Wound Closure as assessed using Bates-Jensen Wound Assessment Tool (BWAT)(and Serial Digital Photography.)
Investigators
Dr Ambanna Gowda
Citizen Hospital, Bangalore