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

NCT07163195 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Venous Leg Ulcer (VLU)
  • Chronic Wound

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.

Sponsors & Collaborators

  • Asmat Burhan

    lead OTHER

Principal Investigators

  • Septian Mixrova Sebayang, MSN · Universitas Harapan Bangsa - Clinic Podiatry Care, Purwokerto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07163195 on ClinicalTrials.gov