| CTRI Number |
CTRI/2025/05/086318 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Controlled Trial to Assess the Efficacy of Deep Tissue Heating in Patients with Severe Diabetic Foot Ulcers |
|
Scientific Title of Study
|
An Open-Label Add-On Randomized Controlled Trial to Assess the Efficacy of Deep Tissue Heating as an Adjuvant Therapy in Patients with Severe Diabetic Foot Ulcers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhasish Sarkar |
| Designation |
Assistant Professor |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
Department of General Surgery OPD, Room No. 2. College of Medicine and Sagore Dutta Hospital. 578 B. T. Road, Kamarhati, Kolkata
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
9564524882 |
| Fax |
|
| Email |
s.sarkar735@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhasish Sarkar |
| Designation |
Assistant Professor |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
Department of General Surgery OPD, Room No. 2. College of Medicine and Sagore Dutta Hospital. 578 B. T. Road, Kamarhati, Kolkata
WEST BENGAL
700058
India |
| Phone |
9564524882 |
| Fax |
|
| Email |
s.sarkar735@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhasish Sarkar |
| Designation |
Assistant Professor |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
Department of General Surgery OPD, Room No. 2. College of Medicine and Sagore Dutta Hospital. 578 B. T. Road, Kamarhati, Kolkata
WEST BENGAL
700058
India |
| Phone |
9564524882 |
| Fax |
|
| Email |
s.sarkar735@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Medicine and Sagore Dutta Hospital. 578 B. T. Road, Kamarhati, Kolkata, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
College of Medicine and Sagore Dutta Hospital |
| Address |
578 B. T. Road, Kamarhati, Kolkata - 700058, West Bengal |
| Type of Sponsor |
Government 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 |
| Dr Subhasish Sarkar |
College of Medicine and Sagore Dutta Hospital |
General Surgery OPD Room No. 2. B. T. Road, Kamarhati, Kolkata - 700058, West Bengal
North Twentyfour Parganas
WEST BENGAL |
9564524882
s.sarkar735@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, CMSDH |
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 |
Microwave Diathermy |
2,450 megahertz Microwave Diathermy intended to produce a therapeutic heat 1 to 2 cm below the skin within specific volumes of the body through the transcutaneous transmission of high frequency electromagnetic (EM) energy.
Duration of intervention in each session will be 15 seconds cycle for 10 minutes.
Intervention will be given twice weekly in OPD clinic of the hospital.
The add on therapy will be continued till healthy granulation is seen on the ulcer wound bed. |
| Comparator Agent |
Standard Wound Management |
Dressing and debridement of wounds using gauge and saline. Medications as and when required. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with diabetic foot ulcers. |
|
| ExclusionCriteria |
| Details |
Individuals with severe comorbidities. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved healing rate, healing time, infection rate, amputation rate. |
Weekly monitoring from baseline. Comparison every 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wound healing rate, infection rate, amputation rate, all cause mortality. |
Baseline, 8 Weeks, 6 months. |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/05/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The
standard treatment guidelines for the prevention and management of diabetic
foot include conventional treatments such as infection management and surgical
interventions. Improvement of blood blow rates in the affected peripheral
tissues of the body improves the accessibility of drugs and tissue repair
proteins and potentially reduces the wound healing time. This adjuvant therapy
would potentially provide a faster therapeutic solution for DFUs. |