Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-30 @ 4:05 PM
Study NCT ID:
NCT07163195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors who evaluate digital wound images and statistical analysts will be blinded to treatment allocation. Participants, care providers, and investigators will not be masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in a 1:1 ratio to either the intervention group (smart bandage plus standard wound care) or the control group (standard wound care alone). Both groups will be followed for 12 weeks in parallel. Randomization will use computer-generated block randomization with allocation concealment. Outcome assessors and data analysts will be blinded to group assignments.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-08-31', 'studyFirstSubmitQcDate': '2025-08-31', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of ulcers achieving complete healing', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 12 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage reduction in wound area', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 12 weeks', 'description': 'Change in ulcer size from baseline, measured using standardized digital photography and analyzed with ImageJ planimetry.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 12 weeks', 'description': '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.\n\nUnit of Measure: points (0-4)'}, {'measure': 'Incidence of clinical infection', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 12 weeks', 'description': 'Presence of infection determined by clinical signs and classified according to the Society for Vascular Surgery WIfI system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venous Leg Ulcer', 'Chronic Wound', 'Smart Bandage', 'Telemonitoring', 'Digital Health', 'Mobile Application', 'Wound Care', 'Wound Healing', 'Randomized Controlled Trial', 'Indonesia'], 'conditions': ['Venous Leg Ulcer (VLU)', 'Chronic Wound']}, 'referencesModule': {'availIpds': [{'id': 'Protocol_V1_2025', 'url': 'https://u.podiatricare.my.id/', 'type': 'Individual Participant Data Set', 'comment': 'The de-identified IPD underlying primary and secondary outcomes, along with the study protocol and SAP, will be available upon reasonable request to the Principal Investigator via email. Access requires a data sharing agreement.'}, {'id': 'SAP_V1_2025', 'url': 'https://u.podiatricare.my.id/', 'type': 'Statistical Analysis Plan', 'comment': 'The statistical analysis plan (SAP) describes predefined methods for analyzing the primary and secondary outcomes, including sample size justification, handling of missing data, and statistical tests. Available upon request to the PI'}, {'id': 'Code_V1_2025', 'url': 'https://u.podiatricare.my.id/', 'type': 'Analytic Code', 'comment': 'Analytic code used for data processing and statistical analyses, including scripts for wound area measurement (ImageJ) and outcome analyses (SPSS/R). The code will be available by request to the PI and requires a data sharing agreement'}], 'seeAlsoLinks': [{'url': 'https://u.podiatricare.my.id', 'label': 'Official study information page hosted by Klinik Podiatry Care, Purwokerto'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': 'Venous leg ulcers (VLUs) are chronic wounds with significant clinical and economic burden. Healing is often delayed due to persistent inflammation, tissue hypoxia, and susceptibility to infection. Smart bandage technologies offer a novel approach by integrating sensors that can continuously monitor wound conditions (pH, temperature, moisture) and transmit data via a mobile application for real-time telemonitoring. This enables wound care providers to adjust treatment promptly and may improve patient engagement and outcomes.\n\nThis randomized controlled trial will compare smart bandage plus standard wound care with standard wound care alone in adult patients with VLUs. The intervention group will receive a smart bandage with pH, temperature, and moisture sensors connected to a secure mobile app monitored by wound care nurses. The control group will receive standard care including compression therapy, conventional dressings, debridement as indicated, and patient education.\n\nThe primary outcome is the proportion of ulcers achieving complete healing within 12 weeks, defined as full epithelialization without drainage. Secondary outcomes include time to healing, percentage wound area reduction (measured by digital planimetry), incidence of clinical infection, and health-related quality of life (Wound-QoL questionnaire). A total of 110 participants will be recruited at Clinic Podiatry Care, Purwokerto, Indonesia.\n\nRandomization will be performed in a 1:1 ratio using computer-generated block randomization. Outcome assessors and data analysts will be blinded. Analyses will follow the intention-to-treat principle, with χ² tests for primary outcomes and generalized estimating equations for repeated measures.\n\nThe study is designed to provide robust clinical evidence on the effectiveness of smart bandage technology combined with telemonitoring in VLU care, with the potential to inform integration of digital wound care into clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Clinically diagnosed venous leg ulcer persisting for more than 3 weeks\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\>65 years (elderly patients excluded)\n* Acute or emergency wounds\n* Mixed etiology ulcers with significant arterial involvement\n* Severe comorbid illness such as end-stage renal failure or active malignancy\n* Cognitive impairment preventing informed consent\n* Allergy to dressing materials'}, 'identificationModule': {'nctId': 'NCT07163195', 'acronym': 'SMART-VLU', 'briefTitle': 'Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Harapan Bangsa'}, 'officialTitle': 'Smart Bandage With App-Based Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial', 'orgStudyIdInfo': {'id': 'VLU-RCT-2025'}, 'secondaryIdInfos': [{'id': 'B.LPPM.UHB/486/05/2025', 'type': 'OTHER', 'domain': 'Universitas Harapan Bangsa'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smart Bandage + Standard Wound Care', 'description': 'Participants in this arm will receive a smart bandage with integrated sensors (pH, temperature, and moisture) connected to a mobile telemonitoring platform. Wound data will be transmitted securely to wound care nurses for review. In addition, patients will receive standard wound care including compression therapy, conventional dressings, sharp debridement when indicated, and patient education.', 'interventionNames': ['Device: Smart Bandage with Telemonitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Bandage + Standard Wound Care', 'description': 'Participants will receive standard wound care (compression therapy, debridement when indicated, and patient education) plus a conventional bandage without digital monitoring features. This represents usual care according to international guidelines', 'interventionNames': ['Device: Conventional Bandage']}], 'interventions': [{'name': 'Smart Bandage with Telemonitoring', 'type': 'DEVICE', 'otherNames': ['Smart wound bandage, Digital wound monitoring bandage'], 'description': '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).', 'armGroupLabels': ['Smart Bandage + Standard Wound Care']}, {'name': 'Conventional Bandage', 'type': 'DEVICE', 'otherNames': ['Standard wound dressing, Non-digital bandage'], 'description': '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.', 'armGroupLabels': ['Conventional Bandage + Standard Wound Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64118', 'city': 'Banyumas', 'state': 'Indonesia', 'country': 'Indonesia', 'contacts': [{'name': 'Asmat Burhan, Master of Nursing Science', 'role': 'CONTACT', 'email': 'asmatburhan1@gmail.com', 'phone': '085746157782'}, {'name': 'Indah Susanti, Master of Science Nursing', 'role': 'CONTACT', 'email': 'indahnoni138@gmail.com', 'phone': '085869181749'}, {'name': 'Septian M Sebayang, Master of Science Nursing', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Podiatry Clinic', 'geoPoint': {'lat': -7.51417, 'lon': 109.29417}}], 'centralContacts': [{'name': 'Indah Susanti, MSN', 'role': 'CONTACT', 'email': 'indahsusanti@uhb.ac.id', 'phone': '+6285869181749'}, {'name': 'Diaz Ibrahim, MSN', 'role': 'CONTACT', 'email': 'diaibrahim@podiatricare.my.id', 'phone': '081391164755'}], 'overallOfficials': [{'name': 'Septian Mixrova Sebayang, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitas Harapan Bangsa - Clinic Podiatry Care, Purwokerto'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'De-identified IPD and supporting information (study protocol, SAP, and analytic code) will be available beginning 6 months after publication of the main trial results and will remain available for 3 years thereafter.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) for primary and secondary outcomes, including baseline demographics, ulcer characteristics, intervention assignment, and outcome data.\n\nTime Frame:\n\nAvailable starting 6 months after publication of the main results, for up to 3 years.\n\nAccess Criteria:\n\nAvailable to qualified researchers with sound proposals consistent with the study objectives.\n\nAccess Method:\n\nBy request to the Principal Investigator via email; access requires a data sharing agreement.', 'accessCriteria': 'De-identified individual participant data (IPD) and supporting information (study protocol, SAP, and analytic code) will be made available to qualified researchers with methodologically sound proposals. Data will be provided for use in research consistent with the original trial objectives. Requests should be directed to the Principal Investigator via email. Access will be granted after review of the proposal and signing of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asmat Burhan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer/Researcher, Faculty of Health Sciences, Universitas Harapan Bangsa', 'investigatorFullName': 'Asmat Burhan', 'investigatorAffiliation': 'Universitas Harapan Bangsa'}}}}