| CTRI Number |
CTRI/2025/10/096240 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Smart Dre-M Wound Dressing is a modern therapeutic device with ayurvedic and synthetic components] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2512 Version No 1.0 Dated 05 Jun 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ambanna Gowda |
| Designation |
Principal Investigator |
| Affiliation |
Citizen Hospital, Bangalore |
| Address |
1st Floor, CR Unit, No.14,
2nd Main, Dispensary Road, Kalasipalya,
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9845270377 |
| Fax |
|
| Email |
dr.ambanagowda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Neurop Pharma Products Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Neurop Pharma Products Pvt Ltd. |
| Address |
26-39-5,Chaitanya Nagar,
Revenue Ward 39, A.T. Agraharam (Guntur), Guntur,
Andhra Pradesh,India-522004. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambanna Gowda |
Citizen Hospital |
No.14, 2nd Main, Dispensary Road, Kalasipalya, Bangalore - 560002
Bangalore
KARNATAKA |
9845270377
dr.ambanagowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Citizen Hospital Inst. Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T304||Corrosion of unspecified body region, unspecified degree, (2) ICD-10 Condition: E106||Type 1 diabetes mellitus with other specified complications, (3) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, (4) ICD-10 Condition: T31||Burns classified according to extent of body surface involved, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
ot applicable (Single-arm study; no comparator group in this pilot trial) |
| Intervention |
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 60, and Day 90)
Details: Applied directly on wound (general, diabetic, or burn wounds) by trained clinical staff |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 cm² and 50 cm² 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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
Baseline - Day 0
Day 30
Day 60
Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 Asssessment |
Baseline - Day 0
Day 30
Day 60
Day 90 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |