CTRI/2025/05/086318RecruitingPhase 2/3
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
College of Medicine and Sagore Dutta Hospital1 site in 1 country50 target enrollmentStarted: May 19, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Improved healing rate, healing time, infection rate, amputation rate.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Individuals with diabetic foot ulcers.
Exclusion Criteria
- •Individuals with severe comorbidities.
Outcomes
Primary Outcomes
Improved healing rate, healing time, infection rate, amputation rate.
Time Frame: Weekly monitoring from baseline. Comparison every 4 weeks.
Secondary Outcomes
- Wound healing rate, infection rate, amputation rate, all cause mortality.(Baseline, 8 Weeks, 6 months.)
Investigators
Subhasish Sarkar
College of Medicine and Sagore Dutta Hospital
Study Sites (1)
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