| CTRI Number |
CTRI/2022/05/042771 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
23/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
MANAGEMENT OF DIABETIC FOOT ULCER BY DIFFERENT TYPES OF DRESSINGS |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL STUDY IN ASSESSING HEALING
RATE USING COLLAGEN SILVER GEL VERSUS
CONVENTIONAL DRESSING IN MANAGEMENT OF
DIABETIC FOOT ULCER
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhusudhan S |
| Designation |
Junior Resident |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of General Surgery,
No.67, BGS Health and Education City, Uttarahalli road, Kengeri, Bangalore
Bangalore
KARNATAKA
560060
India |
| Phone |
9632762784 |
| Fax |
|
| Email |
dr.s.madhusudhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nischal K |
| Designation |
Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of General Surgery,
BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli road, Kengeri, Bangalore
No.67, BGS Health and Education City, Uttarahalli road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9900151574 |
| Fax |
|
| Email |
knischal697@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nischal K |
| Designation |
Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of General Surgery,
BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli road, Kengeri, Bangalore
No.67, BGS Health and Education City, Uttarahalli road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9900151574 |
| Fax |
|
| Email |
knischal697@gmail.com |
|
|
Source of Monetary or Material Support
|
| BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES NO.67, BGS HEALTH AND EDUCATION CITY UTTARAHALLI ROAD KENGERI BANGALORE 560060 KARNATAKA |
|
|
Primary Sponsor
|
| Name |
Dr Madhusudhan S |
| Address |
BGS Global Institute of Medical Sciences,No.67, BGS Health and Education City, Uttarahalli road, Kengeri, Bangalore 560060, Karnataka |
| 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 Madhusudhan |
BGS Global Institute of Medical Sciences |
Room No.201,207, Ground Floor, Department of General Surgery, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9632762784
dr.s.madhusudhan@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Collagen Silver gel |
Under all aseptic precaution wound debridement will be done, cleaned with normal saline. Then collagen silver gel will be applied which will then be covered by gauze and roller bandage. Observations will be made at day 0, day 3, Day 7 ,Day 15 and Day 30 |
| Comparator Agent |
Povidone Iodine |
Patients will be treated with conventional method of dressing with povidone iodine followed by dressing with gauze pad and bandage. Observations will be made at day 0, day 3, Day 7 ,Day 15 and Day 30 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All diabetic patients with Wagner criteria greater than 2
2. Subjects willing to Sign Informed Consent Document |
|
| ExclusionCriteria |
| Details |
1.Previous interventions
2.Bedsores
3.Vascular ulcers
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain using Visual analogue and over all Healing of the Wound |
Days 3,7,10 and 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Over all safety and Adverse Events |
Days 3,7,10 and 15 |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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)
|
28/05/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"NILL" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All patients fulfilling the inclusion criteria will be enrolled for the study. Informed consent will be taken to participate in the study. Cases will be randomized into two groups (odd and even). In the first group, dressing will be done with collagen silver gel. In the second group, dressings will be done with povidone iodine. Group 1: Under all aseptic precautions wound debridement will be done, cleaned with normal saline. Then collagen silver gel will be applied which will then be covered by gauze and roller bandage. The wound will be inspected on 3rd, 7th, 10th and 15thday and compared with that of group 2 in the form of signs of healing, decrease in size, discharge and granulation tissue/epithelisation. Group 2: In this group, patients will be treated with the conventional method of dressing with povidone iodine followed by dressing with gauze pad and bandage. The wound will be inspected on 3rd, 7th, 10th and 15th day. Visual analysis of all the parameters will be recorded in a proforma. |