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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •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.
- •Severe peripheral sensory loss.
- •Non-ambulatory individuals.
- •Uncontrolled systemic illness likely to affect healing like uncontrolled diabetes.
- •Active deep vein thrombosis.
Investigators
Kasturi Alavane
KLE Institute of Physiotherapy