| CTRI Number |
CTRI/2022/05/042786 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
02/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing vaccum assisted dressing vs other conventional dressings in diabetic foot ulcers |
|
Scientific Title of Study
|
A Prospective study on the efficacy of vaccum assisted closure in diabetic foot ulcers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
STEFFIN ANTO |
| Designation |
Post graduate Doctor |
| Affiliation |
Melmaruvathur adhiparasakthi institute of medical science |
| Address |
3rd floor,general surgery department,melmaruvathur adhiparasakthi institute of medical science and research center
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9080743984 |
| Fax |
|
| Email |
steffin345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Habeeb Mohammed |
| Designation |
Professor |
| Affiliation |
Melmaruvathur adhiparasakthi institute medical science and research center |
| Address |
3rd floor,
Department of general surgery,melmaruvathur adhiparasakthi institute of medical science, melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9840161616 |
| Fax |
|
| Email |
habeebmohammed043@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
STEFFIN ANTO |
| Designation |
Post graduate Doctor |
| Affiliation |
Melmaruvathur adhiparasakthi institute medical science and research center |
| Address |
3rd floor general surgery department, adhiparasakthi institute of medical science and research center
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9080743984 |
| Fax |
|
| Email |
steffin345@gmail.com |
|
|
Source of Monetary or Material Support
|
| Melmaruvathur adhiparasakthi institute of medical science and research center |
|
|
Primary Sponsor
|
| Name |
Melmaruvathur adhiparasakthi institute of medical science |
| Address |
Melmaruvathur 603319 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Steffin anto |
Melmaruvathur adhiparasakthi institute of medical science and research center |
General surgery department,3rd floor,melmaruvathur
Kancheepuram
TAMIL NADU |
9080743984
steffin345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E086||Diabetes mellitus due to underlying condition with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional dressings |
Conventional dressings for 1 week |
| Intervention |
Vaccum assisted closure dressing |
Vaccum assisted closure dressing for 1 week |
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All type 2 diabetic patients >30 years of age admitted with diabetic foot ulcer |
|
| ExclusionCriteria |
| Details |
1.coagulopathy
2.ulcer with underlying osteomyelitis
3.wounds resulting from venous insufficiency and arterial disorders
4.wagner grade 5
5.charcots joints |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine duration of wound healing |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of hospital stay,bacterial growth,measuring growth of granulation tissue |
15 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetic foot ulcers are prevalent complication of diabetes millions and account for significant morbidity,mortality and health care expenditures.This study is to compare reduce hospital stay,faster wound healing,bacterial growth in Vaccum assisted dressing vs conventional dressings |