| CTRI Number |
CTRI/2024/02/062866 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of low level laser treatment on wound healing in diabetic ulcer |
|
Scientific Title of Study
|
Effect of low level laser therapy on wound healing in diabetic ulcer |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Babisha P C |
| Designation |
MPT Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of physiotherapy
Sri Ramachandra Institute of Higher Education and Research,
No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9176430454 |
| Fax |
|
| Email |
babishapc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof N Venkatesh |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of physiotherapy
Department of physiotherapy
Sri Ramachandra Institute of Higher Education and Research,
No.1 Ramachandra Nagar Porur, Chennai, 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9444494821 |
| Fax |
|
| Email |
vnk646@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof N Venkatesh |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of physiothrapy
Department of physiotherapy
Sri Ramachandra Institute of Higher Education and Research,
No.1 Ramachandra Nagar Porur, Chennai, 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9444494821 |
| Fax |
|
| Email |
vnk646@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research
(Deemed to be University),
No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| BABISHA P C |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Department of general surgery OPD
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU |
9176430454
babishapc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS DHR/ICMR REG NO: EC/NEW/INST/2023/TN/0321 |
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. Ayurveda Condition: NIL, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | low level laser therapy | (Procedure Reference: Feitosa, Maura Cristina Porto et al. “Effects of the Low-Level Laser Therapy (LLLT) in the process of healing diabetic foot ulcers.†Acta cirurgica brasileira vol. 30,12 (2015): 852-7., Procedure details: low level laser therapy for 3 weeks(7 sessions)
dosage(wavelength):632nm )
| | 2 | Comparator Arm (Non Ayurveda) | | - | standard care | routine care |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with diabetic ulcer
Age 50 to 70 years
Able to provide informed consent |
|
| ExclusionCriteria |
| Details |
Patients with neurological deficit
Unable to enroll for the study duration |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| imitomeasure app, visual analogue scale |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| visual analogue scale |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/03/2024 |
| 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="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
|
Step 1: Literature Search An extensive literature search is done to expand knowledge about the various methods and outcome methods followed for diabetic ulcers. Step 2: Sample Collection The samples are taken for study based on the inclusion and exclusion criteria of the purposive sampling method. The participants are explained clearly about the study and the procedure and are given a consent form that describes the study. They are requested to go through the consent form and then sign it. By doing so, the participant agrees to take part in the study.Step 3: Case Group and Control Group All the participants in the study were pre-tested by measuring the wound size with the imitomeasure app, and the pain scale was noted. The participants are allocated based on simple random sampling. The case group is given low-level laser therapy for 3 weeks with 7 sessions. The control group is treated with medications.Step 4: Comparison After 3 weeks, the size of the wound is measured and compared with the previous ones. The percentage of wound size reduction is calculated, and the results are given. |