| CTRI Number |
CTRI/2024/05/068228 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the effectiveness of 2 dressings in managing the diabetic foot wounds |
|
Scientific Title of Study
|
A study comparing the efficacy of tertiary ammonium compound based foam dressing versus silver based foam dressing in non ischemic diabetic foot ulcer patients using wound ischemia foot infection grading WIFI GRADE 2 in a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shahala Shirin T P |
| Designation |
Junior Resident |
| Affiliation |
Government medical college Kozhikode |
| Address |
Department of general surgery Government medical college Medical College Junction, Mavoor Rd, Kozhikode
Kozhikode KERALA 673008 India |
| Phone |
8075498461 |
| Fax |
|
| Email |
shahalashirintp@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Chandrasekharan S |
| Designation |
Associate professor |
| Affiliation |
Government medical college Kozhikode |
| Address |
Department of general surgery Government medical college Medical College Junction, Mavoor Rd, Kozhikode
Kozhikode KERALA 673008 India |
| Phone |
9446394276 |
| Fax |
|
| Email |
sekhardr@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Chandrasekharan S |
| Designation |
Associate professor |
| Affiliation |
Government medical college Kozhikode |
| Address |
Department of general surgery Government medical college Medical College Junction, Mavoor Rd, Kozhikode
Kozhikode KERALA 673008 India |
| Phone |
9446394276 |
| Fax |
|
| Email |
sekhardr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government medical college Medical College Junction, Mavoor Rd, Kozhikode, Kerala 673008 |
|
|
Primary Sponsor
|
| Name |
Shahala Shirin T P |
| Address |
Department of general surgery Government medical college Medical College Junction, Mavoor Rd, Kozhikode |
| Type of Sponsor |
Other [self] |
|
|
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 Shahala Shirin T P |
Government medical college Kozhikode |
Department of general surgery
Government medical college Medical College Junction, Mavoor Rd, Kozhikode Kozhikode KERALA |
8075498461
shahalashirintp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
Silver based foam dressing |
Combination of inorganic silver and dressing
Will be applied every week for 6 months or until complete healing |
| Intervention |
Tertiary ammonium compound based 3D hydrocellular dressing |
Consists of Tertiary ammonium compound (DTAC) for antimicrobial action and a 3-D Knitted
Hydrocellular textile substrate
made of Polyethylene
Terephthalate (PET) and
Polyurethane (PU)
Will be applied every week for 6 months or until complete healing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Grade 2 diabetic foot ulcer satisfying WIFi classification
2. Willing to give written informed
consent for the study |
|
| ExclusionCriteria |
| Details |
1. Diabetic foot ulcers with underlying ischemia, neuropathy
2. All causes of foot ulcer, which can be attributed to other coexisting diseases like paraplegia, varicose vein, etc.
3. Patient with known hypersensitivity to ammonium or ionic silver
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time duration needed for complete wound healing |
Weekly until complete healing or 6 months post dressing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of debridement and dressings needed |
Weekly until complete healing or 6 months post dressing |
| Cost efficacy |
After complete healing or 6 months |
| Presence of slough as percentage of total ulcer surface area |
Weekly until complete healing or 6 months post dressing |
| Presence of granulation as percentage of total ulcer surface area |
Weekly until complete healing or 6 months post dressing |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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 4 |
|
Date of First Enrollment (India)
|
12/06/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
There are multiple factors
associated with the development of diabetic foot ulcer , such as the complex
process and complications of diabetes, may all lead to various
degrees of neurological
abnormalities and vascular damage. once the ulcer is formed, the factors affecting
healing may be more complex,
and different factors
may dominate at different stages over time. thus, these related
factors play different
roles depending on the severity
of disease and duration of recovery, necessitating different diagnoses and treatments for seemingly
the same symptoms
and causing differences in the curative
effect. in these circumstances, the classification and scoring criteria
for describing lesions of diabetic foot ulcer should be formatted
in a manner that is clinically recognized and widely used, which will allow characterization of diabetic
foot ulcer on the basis of differences and facilitate suggestions for
treatment or care programs. Silver based foam dressings can continuously and effectively release silver ions, kill the wound and surrounding bacteria, improve the wound healing environment, and can also hydrate and soften necrotic tissue and clean the wound. silver ions can bind to negatively charged bacteria, enhance the permeability of the bacterial outer membrane, and induce bacterial apoptosis. the silver dressing has a certain toxic effect on fibroblasts of diabetic patients, which can reduce its cell activity and collagen synthesis, and significantly change cell morphology. some studies have found that silver dressings significantly reduce odour, improve pain-related symptoms, decrease wound exudate, and have a prolonged dressing wear time. Recently, dimethyl tetradecyl ammonium chloride (DTAC) based 3d-hydrocellular wound dressings have emerged. DTAC is a cationic surfactant used at the concentration of 1% w/w, based on DTAC technology, 3d-hydrocellular wound dressing is formulated as a 3- dimensional knitted fabric. The 3-dimensional knitted fabric comprises of DTAC-bounded polyethylene terephthalate (90% w/w) and polyurethane material (10% w/w), forming a 3D hydrocellular structure. DTAC-based dressing acts as a physical barrier against contaminants, helps in gaseous exchange, maintains the moist environment, and manages the exudates effectively. They are primarily used for exuding, minor, chronic and surgical wounds, and first and second-degree burns. The exceptional properties of DTAC technology are the “physical kill mechanism†for microbial protection and the non-leachability of DTAC into the skin or out of the dressing. The cross-linking property ensures that the active component remains bounded to the surface of the dressing. in addition, the DTAC dressings as antimicrobial, cover a broad spectrum of microbes and eradicate the infection load at the wound site |