CTRI

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CTRI Number

CTRI/2026/02/103102 [Registered on: 05/02/2026] Trial Registered Prospectively

Last Modified On:

04/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Effect of Electrical Stimulation on Healing of Diabetic Foot Ulcers

Scientific Title of Study

An AI Enabled Wound Dimension measurement: Effect of Russian current stimulation and High Voltage Pulsed Galvanic Stimulation 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	Kasturi Alavane
Designation	Student(Post Graduate)
Affiliation	KLE Institute of Physiotherapy
Address	KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Cardiovascular and Pulmonary Physiotherapy Department Room No. 6, Nehru Nagar, Belagavi, Karnataka- 590010 Belgaum KARNATAKA Belgaum KARNATAKA 590010 India
Phone	7338612514
Fax
Email	kasturialavane@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Varun Naik
Designation	Associate Professor
Affiliation	KLE Institute of Physiotherapy
Address	KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Cardiovascular and Pulmonary Physiotherapy Department Room No. 6, Nehru Nagar, Belagavi, Karnataka- 590010 Belgaum KARNATAKA Belgaum KARNATAKA 590010 India
Phone	9986497065
Fax
Email	varunnaik@klekipt.edu.in

Details of Contact Person
Public Query

Name	Kasturi Alavane
Designation	Student(Post Graduate)
Affiliation	KLE Institute of Physiotherapy
Address	KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Cardiovascular and Pulmonary Physiotherapy Department Room No. 6, Nehru Nagar, Belagavi, Karnataka- 590010 Belgaum KARNATAKA KARNATAKA 590010 India
Phone	7338612514
Fax
Email	kasturialavane@gmail.com

Source of Monetary or Material Support

KLES Dr. Prabhakar Kore Hospital and MRC Nehru Nagar, Belagavi, 590010

Primary Sponsor

Name	Kasturi Alavane
Address	KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Cardiovascular and Pulmonary Physiotherapy Department Room No. 6, Nehru Nagar, Belagavi, Karnataka- 590010 Belgaum KARNATAKA
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Kasturi Alavane	KLES Dr. Prabhakar Kore Hospital and MRC Nehru Nagar, 590010	KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Cardiovascular and Pulmonary Physiotherapy Department Room No. 6. Belgaum KARNATAKA	7338612514 kasturialavane@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Research and Ethical Committe, KLEU Institute of Physiotherapy, Belagavi	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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	High- voltage pulsed galvanic stimulation	Active electrode placed over wound site, dispersive electrode placed proximally. Turn on HVPGS unit, select high-voltage twin-peaked monophasic mode, setting frequency to 100Hz, selecting starting polarity and will begin with low voltage and gradually increasing to 100-150V depending on patient tolerance. Reduce voltage to zero after 20 mins and remove electrodes.
Intervention	Russian Current Stimulation	Electrode placement- Place one on the proximal healthy tissue and another on the distal side. Turn the device on, select 2500Hz carrier frequency, set burst frequency at 50Hz and adjust intensity slowly. Treatment duration- 20 mins, 6 days a week for a week.

Inclusion Criteria

Age From	40.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	Clinically diagnosed with diabetic foot ulcer involving the plantar and dorsal area attributed to diabetic etiology. Individuals above 40years of age. Patients who present wound since a week period of time. Ulcers of Grade I-III of Wagner Classification. Adequate vascular supply to the affected limb. Receiving standard wound care and are able to comply with adjunctive electrotherapy protocol. Who have partially impaired sensory loss. Ability to participate for the full study duration. Standard wound care is been given based on the grade of the wound. Willing to participate in the study.

ExclusionCriteria

Details

With severe peripheral arterial disease.
Absent distal pulses, severe ischemia.
Hemoptysis.
With active untreated osteomyelitis or deep bone infection in the affected limb.
Presence of implanted electronic devices or other electronic implants in the treatment field.
Known malignancy in or adjacent to the treatment area.
Pregnancy.
Severe peripheral sensory loss.
Non-ambulatory individuals.
Uncontrolled systemic illness likely to affect healing like uncontrolled diabetes.
Active deep vein thrombosis.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Other

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Wound measurement.	Day 1 and Day6

Secondary Outcome

Outcome	TimePoints
Ankle-brachial index and Toe-brachial index.	Once prior to the intervention and once after the intervention.

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)

16/02/2026

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="1"
Months="0"
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

Diabetic foot ulcers are a common and severe complication of diabetes mellitus, often resulting from neuropathy, impaired circulation, and delayed wound healing. Conventional wound care alone frequently fails to achieve timely healing, prompting the need for effective adjunctive therapies. Electrical stimulation has emerged as a promising modality for enhancing tissue repair; however, limited comparative evidence exists regarding the effectiveness of different electrical stimulation techniques in diabetic foot ulcer management.

This randomized clinical trial aims to compare the effectiveness of Russian Current Stimulation and High-Voltage Pulsed Galvanic Stimulation in improving lower-limb circulation and promoting wound healing in individuals with Grade I to Grade III diabetic foot ulcers. A total of 40 participants will be randomly allocated into two intervention groups and treated over a period of 4–6 weeks alongside standard wound care.

Wound healing will be objectively assessed using an AI-enabled wound measurement tool, ensuring accurate and reproducible evaluation of wound dimensions. Secondary outcomes will include circulatory indices (ABI and TBI) and sensory assessment using a biothesiometer.

By integrating advanced electrotherapy modalities with AI-based wound assessment, this study seeks to generate high-quality evidence on their relative efficacy. The findings may help optimize physiotherapy-based interventions, support evidence-based clinical decision-making, and improve healing outcomes in patients with diabetic foot ulcers.