| CTRI Number |
CTRI/2025/10/096211 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/10/2025 |
| 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
|
Comparison of Faradic and Galvanic Stimulation on Wound Healing and Blood Flow in Diabetic Foot Ulcer |
|
Scientific Title of Study
|
A Comparative Study of Faradic and Galvanic Stimulation on Wound Healing and Circulation in Diabetic Foot Ulcer -A Randomized Clinical 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 |
Dr.Peeyoosha Gurudut |
| Designation |
Professor and Head of Department |
| Affiliation |
KLES Institute of physiotherapy belgaum |
| Address |
KLES Dr Prabhakar Kore Hospital and MRC Adavnced physiotherapy centre orthopedic department room no 18 nehru nagar belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Peeyoosha Gurudut |
| Designation |
Professor and Head of Department |
| Affiliation |
KLES Institute of physiotherapy belgaum |
| Address |
KLES Dr Prabhakar Kore Hospital and MRC Adavnced physiotherapy centre orthopedic department room no 18 nehru nagar belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8208077473 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi Gavali |
| Designation |
intern |
| Affiliation |
KLES Institute of physiotherapy belgaum |
| Address |
KLES Dr Prabhakar Kore Hospital and MRC Adavnced physiotherapy centre orthopedic department room no 18 nehru nagar belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8208077473 |
| Fax |
|
| Email |
vaishnavigavali9623@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES INSTITUTE OF PHYSIOTHERAPY |
|
|
Primary Sponsor
|
| Name |
Self sponsored |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC , Advanced Physiotherapy Centre ,Orthopedic Department Room no.18,Nehru Nagar Belagavi,590010 |
| 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 |
| DR PEEYOOSHA GURUDUT |
KLES DR PRABHAKAR KORE HOSPITAL AND MRC |
KLES Dr Prabhakar Kore Hospital and MRC Adavnced physiotherapy centre orthopedic department room no 18 nehru nagar belagavi Karnataka 590010
Belgaum
KARNATAKA |
09844821355
peeyooshagurudut@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KLE ACADEMY OF HIGHER EDUCATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A RANDOMIZED CLINICAL TRAIL |
The intervention will be given by qualified physiotherapist it included two types of electrical stimulation Faradic stimulation and Galvanic stimulation divided into two groups In the FS group the pulse duration set at 100 microseconds with a frequency of 50 Hz The intensity will be adjusted to produce visible muscle contraction without causing pain. Each session lasted for 30 minutes with a frequency of three sessions per week continued for a total duration of three weeks 9 Sessions
In GS group, the pulse duration was also 100 microseconds, with a frequency of 100 pulses per second The intensity will be set according to the patient’s tolerance Similar to FS the session duration will be 30 minutes administered three times per week for a total of three weeks 9 Sessions |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Between the age group of 40-70 years.
Diagnosed with type 2 diabetes having ulcer and referred by surgeon.
Ulcer grade according to Wagner’s classification
With sensory integrity in the category of green and blue according to WEST classification using monofilament
Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
With cardiac pacemaker or any other implanted electronic devices hearing aids
Implants near ulcer area
Skin malignancies
Who have cognitive impairment
Uncontrolled diabetes status HbA1c – 10% or higher
Contraindication of electrical stimulation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
IMITOMEASURE
PODOLOGICAL ASSESSMENT TOOL |
imitomeasure and PODOLOGICAL Assessment Tool pre and post intervention (3weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/11/2025 |
| 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
|
TITLE A COMPARATIVE STUDY OF FARADIC AND GALVANIC STIMULATION
ON WOUND HEALING AND CIRCULATION IN DIABETIC FOOT ULCER A RANDOMAIZED CLINICAL
TRIAL Objective –
To compare the effect of faradic and galvanic stimulation on wound healing and
circulation using podological assessment tool and wound surface area by
photography using imito app in participants with diabetic foot ulcer. INCLUSION
CRITERIA Participants :-
·
Between the age group of 40-70 years.
·
Diagnosed with type 2 diabetes having ulcer and
referred by surgeon.
·
Ulcer grade according to Wagner’s classification.[5]
·
With sensory integrity in the category of green and
blue according to WEST classification using monofilament.[6]
·
Willing to participate in the study.
EXCLUSION CRITERIA Participant :-
- With cardiac pacemaker or any other implanted electronic devices hearing
aids
- Implants near ulcer area
- Skin malignancies
- Who have cognitive impairment
- Uncontrolled diabetes status ( HbA1c – 10% or higher)
- Contraindication of electrical stimulation
OUTCOME MEASURES: -
IMITOMEASURE:- Measure Wound
(app to measure wound)The imitoMeasure app is a helpful and practical way to
measure an area that has high accuracy and repeatability. Imito is a noncontact
digital planimetry app that offers a benefit over alternative techniques. The
imitoMeasure app is a helpful and practical way to measure an area that has
high accuracy and repeatability (ICC score :0.98)Assessment will be done 2
times that is pre and post by a qualified physiotherapist. Components are
checked by wound area, circumference and depth
PODOLOGICAL ASSESSMENT TOOL [9,10]
It is tool used for the diagnosis of diabetic foot ulcers,there are
various components are present, :
1.Biothesiometer – for vibration perception threshold (VPT) to
assess neuropathy.
2.Doppler probes – for vascular assessment.
3.Foot pressure measurement systems – for identifying high-risk plantar
pressure zones |