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NCT07163195
Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
Conditions: Venous Leg Ulcer (VLU), Chronic Wound
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Asmat Burhan
Location: Podiatry Clinic Banyumas Indonesia
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.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 to 65 years
* Clinically diagnosed venous leg ulcer persisting for more than 3 weeks
* Able to provide written informed consent
Exclusion Criteria:
* Age \>65 years (elderly patients excluded)
* Acute or emergency wounds
* Mixed etiology ulcers with significant arterial involvement
* Severe comorbid illness such as end-stage renal failure or active malignancy
* Cognitive impairment preventing informed consent
* Allergy to dressing materials
Source: ClinicalTrials.gov (NCT07163195). StuddyBuddy aggregates publicly available trial information.
