A clinical study to understand if the Smart Dre-M wound dressing is safe and helps in healing wounds caused by any injury, diabetes, or burns.

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. - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096240

Enrollment

Registered

2025-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T304- Corrosion of unspecified body region, unspecified degree Health Condition 2: E106- Type 1 diabetes mellitus with other specified complications Health Condition 3: E116- Type 2 diabetes mellitus with other specified complications Health Condition 4: T31- Burns classified according to extent of body surface involved

Interventions

Intervention1: Smart Dre-M Nanofibrous Bioactive Enriched Wound Dressing: Route of Administration: Topical (applied over wound) Dosage Regimen / Frequency: One dressing per application

change every 7 days or earlier in case of (excess exudation, dressing dislodgement, clinical indication - infection, leakage or odor) Duration: 90 days. (Applications at Baseline (Day 0), Day 30, Day

no comparator group in this pilot trial)

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects aged between 18 and 65 years. 2. Presence of general, diabetic, or burn wounds, of duration less than 6 months. 3. Wound size between 1 cm and 50 cm and located at accessible body sites for dressing application. 4. Ability and willingness to provide written informed consent. 5. Willingness to comply with study procedures and return for scheduled follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Participation in another interventional clinical study within the past 30 days. 2. Known or suspected pregnancy or currently breastfeeding. 3. Presence of malignancy, autoimmune skin conditions, or wounds of venous/ischemic origin. 4. History of severe allergy to dressing components (chitosan, gelatin, PVA, herbal extracts, copper). 5. Active local or systemic infection requiring systemic antibiotics at the time of enrollment. 6. Subjects with poor peripheral perfusion or non-palpable distal pulses (for diabetic wounds). 7. Significant comorbidities (e.g., uncontrolled diabetes, renal or hepatic failure) that may interfere with wound healing or data interpretation. 8. Known substance abuse (alcohol, tobacco, or narcotics) that may impair healing or protocol compliance. 9. Inability or unwillingness to provide consent or adhere to study requirements.

Design outcomes

Primary

Measure	Time frame
Wound Healing as Assessed by Wound Size Reduction and PUSH Tool 1. Endpoint Description Measurement Parameters: a) Wound Size (cm square) b) PUSH Tool Score Timepoint: Baseline - Day 0 Day 30 Day 60 Day 90	—

Secondary

Measure	Time frame
Time to Complete Wound Closure as assessed using Bates-Jensen Wound Assessment Tool (BWAT) and Serial Digital Photography. Pain Assessment as measured by Visual Analogue Scale (VAS). Safety and tolerability AsssessmentTimepoint: Baseline - Day 0 Day 30 Day 60 Day 90	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026