Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAsmat Burhan
About this trial
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
Qualifiers
Adults aged 18 to 65 years
Clinically diagnosed venous leg ulcer persisting for more than 3 weeks
Able to provide written informed consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- Smart Bandage with Telemonitoring
- Conventional Bandage
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Asmat Burhan
Lead sponsor
Universitas Harapan Bangsa
Sponsor institution
Source ClinicalTrials.gov