Clinical Trial

Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial

Study acronym: SMART-VLU
Not Yet Recruiting
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Summary
Venous leg ulcers (VLUs) are chronic wounds that are often slow to heal and can greatly affect patients' daily lives. This study will evaluate a new "smart bandage" that can monitor wound conditions such as pH, temperature, and moisture, and transmit this information to a mobile app for nurses to review. Care can then be adjusted in real time. The purpose of this randomized controlled trial is to compare smart bandage plus standard wound care with standard wound care alone. We will assess whether the smart bandage improves healing rates within 12 weeks, shortens time to healing, reduces infection, and improves quality of life in patients with VLUs. About 110 adult participants with VLUs will be enrolled at Clinic Podiatry Care, Purwokerto, Indonesia.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-04-30 -> 2026-12-27 2026-06-05
minor Completion pushed: 2026-06-30 -> 2027-01-27 2026-06-05
Trial Details
NCT Number NCT07163195
Lead Sponsor Asmat Burhan
Conditions Venous Leg Ulcer (VLU), Chronic Wound
Enrollment 110 participants
Start Date 2026-07-26
Primary Completion 2026-12-27 (estimated)
Study Completion 2027-01-27 (estimated)
Updated on ClinicalTrials.gov 2026-06-04