| CTRI Number |
CTRI/2025/06/088067 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of local insulin in the treatment of diabetic ulcer. |
|
Scientific Title of Study
|
Effects of local insulin application on wound healing in patient with diabetic ulcer by push ( pressure ulcer score for healing) scoring system. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riddhi Thakor |
| Designation |
Junior Resident |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department Of General Surgery, AVBRH Hospital, Jawaharlal Nehru Medical College, Sawangi,
Wardha
MAHARASHTRA
442004
India |
| Phone |
9909209551 |
| Fax |
|
| Email |
riddhithakor99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshana Tote |
| Designation |
Professor, Department of General Surgery |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Surgery, 4th Floor, SMSC Building, AVBRH Hospital Campus, Sawangi Meghe
Wardha
MAHARASHTRA
442004
India |
| Phone |
9923129974 |
| Fax |
|
| Email |
drtotedarshana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshana Tote |
| Designation |
Professor, Department of General Surgery |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Surgery, 4th Floor, SMSC Building, AVBRH Hospital Campus, Sawangi Meghe
Wardha
MAHARASHTRA
442004
India |
| Phone |
9923129974 |
| Fax |
|
| Email |
drtotedarshana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research, Sawangi, Wardha, Maharashtra, India. 442001 |
|
|
Primary Sponsor
|
| Name |
Riddhi Thakor |
| Address |
Department of General Surgery, Jawaharlal Nehru Medical College, DMIHER, Wardha, Sawangi, Maharashtra 442004 |
| 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 Riddhi Thakor |
Acharya Vinoba Bhave Rural Hospital |
Department of General Surgery, 4th Floor, SMSC Building, AVBRH Hospital Campus, Sawangi Meghe
Wardha
MAHARASHTRA |
9909209551
riddhithakor99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local application of insulin injection over diabetic ulcer |
Whether the application of local insulin helps in faster wound healing in patients with diabetic ulcers |
| Comparator Agent |
Normal saline |
Normal saline dressing over diabetic ulcer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All diabetic patients with ulcers
2. Patient over 18 years of age
3. Patient is willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients who are immunocompromised or HIV/HBsAg/anti-HCV positive.
2. The patients with malignancy.
Patients who do not complete treatment because of financial or social constraints.
3. Patients who were not consenting.
4. Patient showing frequent hypoglycemia on topical application of insulin. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of diabetic ulcer after local insulin application |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess effect of topical application of insulin on blood glucose level |
21 Days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/07/2025 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This will be an observational study of 62 patients diagnosed with DIABETIC ULCER coming to
the emergency and OPD in department of general surgery in tertiary care hospitals from march
2024–February 2026. History, clinical examination and symptoms at the time of presentation shall be documented
along with the diagnosis and blood investigation. From the time the patient gets admitted, they
shall be followed up until discharge. 12 hourly dressing will be done by topical insulin application under aseptic precautions.
sugar level 15 minutes pre-dressing and 1 hour post-dressing will be monitored. The Assessment of status of slough and wound size will be done by PUSH scoring system at
day 1 day 7 , day 14 and day 21 of topical insulin dressing. Ulcers will be categorized with respect to surface area, exudate, and type of wound tissue.
record will be ascertained for sub-score of each of these ulcer characteristics. Add the sub
scores to obtain the total score. A comparison of total scores measured over time will provide an
indication of the improvement or deterioration in pressure ulcer healing. |