| CTRI Number |
CTRI/2025/10/096176 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study on the added benefit of Russian current therapy with regular wound dressing for faster healing, and better working ability in people with diabetic foot ulcer |
|
Scientific Title of Study
|
Added Effect of Russian Current Along With Standard Surgical Dressing for Healing, Foot Pressure and Functional Recovery in Diabetic Foot Ulcer: A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay Kage |
| Designation |
Dean and Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advance physiotherapy centre, room number 39, department of orthopaedic, physiotherapy, Sagar floor, KLE Dr Prabhakar Kore hospital and medical research Centre
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Annie Fernandes |
| Designation |
Intern |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
advanced physiotherapy Centre, room number 39, Department of orthopaedic physiotherapy, Sagar floor, KLE Dr Prabhakar Kore Hospital and medical research Centre.
Belgaum
KARNATAKA
590010
India |
| Phone |
8884571902 |
| Fax |
|
| Email |
fernandesannie2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Annie Fernandes |
| Designation |
Intern |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advance physiotherapy Centre, room number 39, department of orthopaedic, physiotherapy, Sagar floor, KLE Dr Prabhakar Kore Hospital and medical research Centre.
KARNATAKA
590010
India |
| Phone |
8884571902 |
| Fax |
|
| Email |
fernandesannie2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advanced physiotherapy Centre, room number 39, Department of orthopaedic physiotherapy, Sagar floor, KLE Dr Prabhakar Koli Hospital and medical research Centre Belgavi, Karnataka, 590010 |
|
|
Primary Sponsor
|
| Name |
Annie Fernandes |
| Address |
KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka ,590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Anosh Chudasama |
KAHER Insititute of Physiotherapy, Nehru Nagar, Belgavi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Annie Fernandes |
KAHER institute of physiotherapy |
Advanced physiotherapy centre,Room no. 39,Department of Orthopaedic manual therapy,Sagar floor,KLE Dr. Prabhakar Kore hospital and Medical Research centre, Belgaum,Karnataka,590010
Belgaum
KARNATAKA |
8884572902
fernandesannie2002@gmail.com |
| Annie Fernandes |
KLE Dr Prabhakar Kore Hospital and medical research Centre |
Advanced physiotherapy Centre,room number 39, department of orthopaedic physiotherapy, Sagar floor.
Belgaum
KARNATAKA |
8884572902
fernandesannie2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and etchical committee |
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 |
| Comparator Agent |
Standard Surgical dressing |
Standard surgical dressing protocol upon diagnosis of grade 1 and 2 diabetic foot ulcer
The dressing kept for 4 weeks and changed alternate days |
| Intervention |
Use of Russian Current along with standard surgical procedure on foot pressure and functional recovery and healing in diabetic foot ulcer |
Russian current given for 2 weeks, 5 days per week for a period of 15 mins at region close to ulcer site (grade 1 and 2 according to Wagner Classification) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with type 2 diabetes and having ulcers in lower limb region
2.Diabetic foot ulcer Grade 1 and 2 according to Wagner’s Classification
3.Participants willing to participate in the study
4. Participants with sensory integrity in the category of green and blue according to the WEST classification using monofilaments |
|
| ExclusionCriteria |
| Details |
1.Cardiac pacemakers
2. Skin malignancies
3.Diabetic ketoacidosis
4. Complete sensory loss
5. Uncontrolled Diabetes status or fluctuating blood sugar. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)imito wound application
2)Diabetic foot analyser
3)DFS-SF-quality of life scale |
Before intervention and after 2 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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="0"
Months="6"
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 randomized controlled trial aims to evaluate the added effect of Russian current stimulation along with standard surgical dressing in promoting wound healing, improving plantar foot pressure, and enhancing functional recovery in patients with diabetic foot ulcers. A total of 22 participants with Wagner Grade I and II diabetic foot ulcers will be randomly allocated into two groups: one receiving standard surgical dressing alone (control group) and the other receiving Russian current therapy in addition to standard dressing (intervention group). The study will be conducted over six months at a tertiary care hospital in Belagavi. Outcome measures will include wound healing assessed using the ImitoWound app, plantar pressure using the Diabetic Foot Analyzer, and quality of life using the Diabetic Foot Ulcer Scale (DFS-SF). The study hypothesizes that Russian current, through improved local circulation and muscle activation, will accelerate healing and functional recovery compared to standard care alone. |