| CTRI Number |
CTRI/2026/02/103795 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
New Wound Treatment Versus Traditional Dressing in Diabetic Foot Ulcers |
|
Scientific Title of Study
|
Vacuum Assisted Closure Therapy vs Conventional Dressing in the Management of Patient with Diabetic Foot Ulcer A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr kartik gill |
| Designation |
Junior Resident |
| Affiliation |
S Nijalingappa Medical College and HSK Hospital Bagalkot |
| Address |
Department of General Surgery S Nijalingappa Medical College Navanagar Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
8708765932 |
| Fax |
|
| Email |
Kartikgill@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhimanagouda V Goudar |
| Designation |
Professor |
| Affiliation |
S Nijalingappa Medical College and HSK Hospital Bagalkot |
| Address |
Department of General Surgery S Nijalingappa Medical College Navanagar Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
8123445819 |
| Fax |
|
| Email |
dr.bvgoudar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr kartik gill |
| Designation |
Junior Resident |
| Affiliation |
S Nijalingappa Medical College and HSK Hospital |
| Address |
Department of General Surgery S Nijalingappa Medical College Navanagar Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
8708765932 |
| Fax |
|
| Email |
Kartikgill@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery S Nijalingappa Medical College and HSK Hospital and Research Centre navanagar Bagalkot 587102 karnataka State India |
|
|
Primary Sponsor
|
| Name |
Dr Kartik Gill |
| Address |
Department of General Surgery S Nijalingappa Medical College and HSK Hospital and Research Centre navanagar Bagalkot 587102 karnataka state India |
| 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 Kartik Gill |
S Nijalingappa Medical College and HSK Hospital Bagalkot |
Department of General surgery First floor S Nijalingappa Medical College and HSK Hospital navanagar Bagalkot 587102
KARNATAKA
Bagalkot
KARNATAKA |
8708765932
Kartikgill@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SNMC BAGALKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L76-L76||Intraoperative and postprocedural complications of skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Dressing |
Conventional Dressing in Management of Patient with Diabetic Foot Ulcer For 18 Months |
| Intervention |
Vacuum Dressing |
Vacuum Asisted Closure Therapy in Management of Patient with Diabetic Foot Ulcer for 18 Months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18
Patients With Ulcer size Less Than 100 cm square of Wagnar Grade 1 and 2
Patients Consenting to Participate in Study |
|
| ExclusionCriteria |
| Details |
Patients with Coagulopathy Venous Disease Ulcers With Underlying Osteomyelitis and Gangrene |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rate of Wound Healing
Rate of Granulation Tissue |
On Day 5 and Day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2026 |
| 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="6"
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
|
Diabetic foot ulcers represent one of the most challenging complications of diabetes mellitus They often lead to prolonged morbidity an increased risk of infection and possible lower limb amputation Effective wound management is essential to improve healing outcomes and reduce the burden on healthcare systems This prospective randomized controlled trial was designed to compare the effectiveness of vacuum assisted closure therapy versus conventional dressing methods in the treatment of patients with diabetic foot ulcers Participants diagnosed with diabetic foot ulcers were randomly assigned to receive either vacuum assisted closure therapy or standard wound care using conventional dressings Vacuum assisted closure therapy involves the application of controlled negative pressure to the wound environment This helps in the removal of exudate reduction of edema promotion of granulation tissue formation and improvement of local blood flow In contrast conventional dressings usually involve regular wound cleaning and the application of gauze or similar materials without active pressure The study will evaluate several clinical outcomes including wound healing and the rate of granulation tissue formation The expected outcome is that patients treated with vacuum assisted closure therapy will experience significantly faster wound healing and greater reduction in wound dimensions compared to those receiving conventional dressings |