CTRI/2023/02/049571 [Registered on: 09/02/2023] Trial Registered Prospectively
Last Modified On:
02/02/2023
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Medical Device
Study Design
Single Arm Study
Public Title of Study
A study to check the effect of wound dressing in long standing wounds of leg
Scientific Title of Study
A prospective, single-arm study to assess the effectiveness and safety of Theruptor Novo dressing pad in the treatment of chronic lower extremity wounds
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
FS-2022-01; V1; 05/12/2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sanjay Sharma
Designation
Podiatric Surgeon & Wound Care Specialist
Affiliation
FootSecure clinic
Address
FootSecure Clinic, RxDx, Third Floor, Plot No. 7G, Opp. Graphite India, EPIP Zone, Whitefield
Bangalore KARNATAKA 560048 India
Phone
9980772658
Fax
Email
sanjay@footsecure.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Sharma
Designation
Podiatric Surgeon & Wound Care Specialist
Affiliation
FootSecure clinic
Address
FootSecure Clinic, RxDx, Third Floor, Plot No. 7G, Opp. Graphite India, EPIP Zone, Whitefield
Bangalore KARNATAKA 560048 India
Phone
9980772658
Fax
Email
sanjay@footsecure.com
Details of Contact Person Public Query
Name
Dr Sanjay Sharma
Designation
Podiatric Surgeon & Wound Care Specialist
Affiliation
FootSecure clinic
Address
FootSecure Clinic, RxDx, Third Floor, Plot No. 7G, Opp. Graphite India, EPIP Zone, Whitefield
RxDx, Third Floor, Plot No. 7G, Opp. Graphite India, EPIP Zone, Whitefield, 560048 Bangalore KARNATAKA
9980772658
sanjay@footsecure.com
Details of Ethics Committee
No of Ethics Committees= 3
Name of Committee
Approval Status
Ethics Committee Telerad RxDx Healthcare Pvt. Ltd
Approved
Ethics Committee Telerad RxDx Healthcare Pvt. Ltd
Approved
Ethics Committee Telerad RxDx Healthcare Pvt. Ltd
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L979||Non-pressure chronic ulcer of unspecified part of lower leg,
Intervention / Comparator Agent
Type
Name
Details
Intervention
3D hydrocellular structure dressing pad
3D hydrocellular dressing pad is made of Polyethylene terephthalate (PET), polyurethane (PU) and Dimethyl Tetradecyl [3(trimethoxysily) propyl] ammonium chloride (DTAC). The wound dressing will be done from visit 1 to visit 9, that is on day 1, 7, 14, 21, 28, 35, 42, 49 and 56
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male and female patients aged above 18 years with ≤ 3 wounds in the lower extremity considered for the study
2. Patient with a low to moderate exuding lower extremity wound with size ≤ 8 cm × 8 cm, with less than 50% of contraction in the past 4 weeks even after standard treatment
3. Patient willing to give written informed consent and adhere to study procedures
ExclusionCriteria
Details
1. Patients with wounds caused by venous or arterial insufficiency, or electrical or chemical burns
2. Patients with wounds showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
3. Patients with history of active Charcoat’s foot of the study foot within 6 months of screening
4. Patients with severe or poorly controlled diabetes mellitus with severe hyperglycaemia (HbA1C >12%)
5. Patients with progressive weight loss
6. Patients undergoing treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, or radiotherapy
7. Patients with history of other diseases, which can alter the normal healing of the wound such as connective tissue disease, renal failure, liver failure, and malignancy
8. Patients who underwent revascularization surgery in the last 8 weeks
9. Patients with ankle-brachial index(ABI) < 0.7
10. Pregnant or lactating mothers
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The percentage of wound contraction as calculated by using the initial and final area every week for 8 weeks by using graded sterile centimeter ruler sterile scale
Day 7, 14, 21, 28, 35, 42, 49 & 56
Secondary Outcome
Outcome
TimePoints
Wound dimensions, wound edge, type of tissue in the wound bed, the depth of the wound, exudate of the wound, Peri-wound skin and presence of infection/inflammation will be assessed by using RESVECH 2.0 scale
Day 1, 7, 14, 21, 28, 35, 42, 49 & 56
Visual analogue scale (VAS) is used to assess pain every week during dressing pad removal
Day 7, 14, 21, 28, 35, 42, 49 & 56
Subject satisfaction of wound healing using 5-point scale
Day 7, 14, 21, 28, 35, 42, 49 & 56
Wound360 version 1.1 application is used for wound characterization and photography
Day 1, 7, 14, 21, 28, 35, 42, 49 & 56
To assess adverse events
Day 7, 14, 21, 28, 35, 42, 49 & 56
Target Sample Size
Total Sample Size="49" Sample Size from India="49" 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
Post Marketing Surveillance
Date of First Enrollment (India)
15/02/2023
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
none yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Wound healing is a complex sequence of events that begins with injury and ends with successful closure.Wound healing process consists of a highly integrated and overlapping phases that is critical in maintaining the normal function of skin. Wound treatment is different in everybody and often depends on the number of factors. Age, skin type, type of wound, location, and severity are some of the factors which depends on treating wound and avoiding infection.
With many disease processes, the cascade of events involved in wound healing can be affected, resulting in chronic, non-healing wounds. All wounds have the potential to become chronic wounds.Understanding and addressing the challenges in the treatment of chronic wounds will lead to a better clinical outcome (faster and more durable wound closure), and avoid inappropriate treatment that may cause deterioration of the wound, delay wound healing, or harm the patient, resulting in improved patient quality of life and reduced healthcare costs.
The ideal dressing should keep the wound moist but not macerated, limit bacterial overgrowth, keep odour to a minimum, and be comfortable to wear. Important criteria to consider before choosing a specific wound dressing are cleaning, absorbing, regulating, and the need to add medication. It is important that the dressings be removed atraumatically, to avoid further damage to the wound surface during dressing changes
Theruptor Novo is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, minor wounds and surgical wounds; to secure and prevent movement of a primary dressing; and as a wound packing. It is a 3D hydrocellular structure (moisture management) dressing pad, which is made of Polyethylene terephthalate, polyurethane and Dimethyl Tetradecyl [3(trimethoxysily) propyl] ammonium chloride (DTAC) for antimicrobial action.
· This study is done to assess the efficacy and safety of Theruptor Novo dressing pad in patients with chronic
lower extremity wound