| CTRI Number |
CTRI/2024/05/066944 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Chronic non-healing diabetic foot ulcer healing using near infra-red laser and conventional saline dressing |
|
Scientific Title of Study
|
Chronic non-healing diabetic foot ulcer-RCT study-using near infra-red laser and conventional saline dressing |
| 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 Sivaguru |
| Designation |
Post graduate |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
no 22 salai street
muthialpet
puducherry
Pondicherry
PONDICHERRY
605003
India |
| Phone |
8056529597 |
| Fax |
|
| Email |
drsivaguru55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G V Manoharan |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Room no:11, professor quarters
Sri manakula vinayagar medical college and hospital, kalitheerthalkuppam, madhagadipet
PONDICHERRY
605107
India |
| Phone |
9443112296 |
| Fax |
|
| Email |
gvmfhm@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sivaguru |
| Designation |
Post graduate |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
no 22 salai street
muthialpet
puducherry
PONDICHERRY
605003
India |
| Phone |
8056529597 |
| Fax |
|
| Email |
drsivaguru55@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sivaguru |
| Address |
no 22 salai street
muthialpet
puducherry |
| Type of Sponsor |
Other [myself] |
|
|
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 sivaguru |
Sri Manakula Vinayagar Medical College and Hospital |
Hospital block second floor clinical department, department of general surgery
Pondicherry
PONDICHERRY |
8056529597
drsivaguru55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri manakula vinayagar medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In the comparative group conventional saline dressing is applied |
For the placebo the conventional saline dressing is done for a period of two weeks |
| Intervention |
management of diabetic foot ulcer near infra red laser |
Diabetic wound is debrided and near infra red laser application was done for a period of two weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.patients with chronic non healing diabetic foot ulcer (more than 3 weeks)
2.Depth ischaemia classification- grade I foot ulcer
3.the patient who understood the compliance as they were required to undergo the respective treatment for two weeks |
|
| ExclusionCriteria |
| Details |
1. Patient with any associated co-morbidities like PVD
2. Patient with deep ulcers with exposed tendons and bone
3. patient with uncontrolled glycemic index |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the improvement of wound in chronic non healing diabetic foot ulcer using near infra red laser and conventional saline dressing |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to understand and predict the reduction in wound surface area by exposing to infra red laser application in chronic non healing diabetic foot ulcers |
2 weeks |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2024 |
| 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
|
Chronic wound is defined as one that fails to heal in the expected time for a wound of that type, which is usually less than 3 weeks. The number of patients with chronic non healing wound are likely to increase as a result of an ageing population and raising incidence of risk factors for atherosclerotic disease such as diabetes and smoking. Diabetes is a complex metabolic disease where lower limb wound are more prevalant. Foot ulceration is the major problem commonly encountered in patients with diabetes mellitus, The factors implicated being a triad of arterial disease, neuropathy, infection. The ulcers result in a chronic wound, which is resistant to treatment and may lead to catastrophic sequele. Wound dressing has been the mainstay, but it requires compliance from the patient for a long period. Many forms of adjuvant treatment have been tried to speed up the healing process of diabetic foot ulcer. One of these mode of treatment is near infra red laser therapy (NIR). It will penetrate deep into tissued and are applied to treat deep seated tissues. Lights in this specific range reach direct target in the cell causing an increase in the photon on the wound surface and speeding up the rate of wound healing. The absorbed laser energy stimulates molecules and atom of cells but does not cause rapid or significant increase in tissue temperature. The aim of this randomized control study is to understand and predict the reduction in wound surface area by exposing to infra red laser application in chronic non healing diabetic foot ulcer |