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NOT YET RECRUITING
NCT07163195
NA

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

Sponsor: Asmat Burhan

View on ClinicalTrials.gov

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.

Official title: Smart Bandage With App-Based Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-02-01

Completion Date

2026-06-30

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DEVICE

Smart Bandage with Telemonitoring

A 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).

DEVICE

Conventional Bandage

A 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.

Locations (1)

Podiatry Clinic

Banyumas, Indonesia, Indonesia