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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Smart Bandage with Telemonitoring
DeviceA smart wound bandage with integrated sensors (pH, temperature, moisture) connected to a mobile telemonitoring platform. Wound data are transmitted securely to a mobile application monitored by wound care nurses. The device is applied in addition to standard wound care (compression therapy, conventional dressing, debridement when indicated, and patient education).
Conventional Bandage
DeviceA conventional wound bandage without digital monitoring features. It is applied in addition to standard wound care (compression therapy, conventional dressing, debridement when indicated, and patient education). This represents usual care according to international guidelines.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Smart Bandage + Standard Wound CareExperimental treatment 1 intervention
Group B: Conventional Bandage + Standard Wound CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of ulcers achieving complete healing
Complete healing is defined as full epithelialization of the ulcer without drainage, confirmed at two consecutive visits by wound care nurses using standardized clinical assessment.
Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeksSecondary outcomes
1
Percentage reduction in wound area
Change in ulcer size from baseline, measured using standardized digital photography and analyzed with ImageJ planimetry.
Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks2
Health-related quality of life
Wound Quality of Life questionnaire (Wound-QoL-17). Report global score and three subscales: Body/Physical, Psyche/Psychological, Everyday life. Scores are calculated as the mean item on a scale of 0-4; range 0-4, and higher scores = poorer quality of life (greater impairment). Reported as change from baseline at each time point. Unit of Measure: points (0-4)
Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks3
Incidence of clinical infection
Presence of infection determined by clinical signs and classified according to the Society for Vascular Surgery WIfI system.
Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Asmat Burhan
Lead sponsor
Universitas Harapan Bangsa
Sponsor institution
Source ClinicalTrials.gov
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