| CTRI Number |
CTRI/2017/07/009147 [Registered on: 27/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects Limited access dressing in patients with Diabetic ulcers.
|
|
Scientific Title of Study
|
Biochemical study of granulation tissues modulated by negative pressure under LAD in Diabetic wounds |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Honnegowda TM |
| Designation |
Research Scholar |
| Affiliation |
Kasturba Medical college and Hospital, Manipal, Karnataka, India |
| Address |
Dept. of Plastic Surgery and Burns, Kasturba Medical college and Hospital Manipal Karnataka India.
Udupi
KARNATAKA
576104
India |
| Phone |
918453881779 |
| Fax |
|
| Email |
honnegowda33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Honnegowda TM |
| Designation |
Research Scholar |
| Affiliation |
Kasturba Medical college and Hospital, Manipal, Karnataka, India |
| Address |
Dept. of Plastic Surgery and Burns, Kasturba Medical college and Hospital Manipal Karnataka India.
Udupi
KARNATAKA
576104
India |
| Phone |
918453881779 |
| Fax |
|
| Email |
honnegowda33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Kumar |
| Designation |
Prof & Head |
| Affiliation |
Kasturba Medical college & Hospital, Manipal, Karnataka, India |
| Address |
Dept. of Plastic Surgery and Burns, Kasturba Medical college & Hospital
Manipal Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
919901700052 |
| Fax |
|
| Email |
pkumar86@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Manipal University, Manipal, Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Honnegowda TM |
Kasturba Hospital, Manipal Plastic Surgery & Burns ward |
CVR hostel Room No. 110 Manipal university
Udupi
KARNATAKA |
8453881779
08202922229
honnegowda33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic Ulcers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional dressing |
Wounds were washed with saline before dressing.Dressing will be changed every alternative day. The treatment process continue until wound heal. |
| Intervention |
Limited access dressing |
Negative pressure wound
therapy and moist wound
healing. Each LAD dressing can
keep upto 10-15 days and
Wounds were washed with
saline daily through the ports
which access into LAD
dressing. The treatment process
continue until wound heal |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic wounds |
|
| ExclusionCriteria |
| Details |
Patients with collagen disorders, Leprosy patients, Pregnant women,
Liver cirrhosis, HIV +ve patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Collagen content (Hydroxyproline) in the
granulation tissue |
zero day and 10th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
hexosamine, total protein, and antioxidants
[reduced glutathione (GSH), glutathione
peroxidase (GPx), glutathione s-transferase
(GST), catalase (CAT), thiol], wound surface pH,
matrix metalloproteinase-2 (MMP-2), and
oxidative biomarker malondialdhyde (MDA) were
measured in the granulation tissue of diabetic wounds |
After 10 days of treatment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/12/2016 |
| 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="2"
Months="0"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary outcome measures will be level of hydroxyproline in the wound granulation tissue.The secondary outcomes were hexosamine, total protein, and antioxidants [reduced glutathione (GSH), glutathione peroxidase (GPx), glutathione s-transferase (GST), catalase (CAT), thiol], wound surface pH, matrix metalloproteinase-2 (MMP-2), and oxidative biomarker malondialdhyde (MDA) were measured in the granulation tissue. |