At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
TWB-103drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Treating Lower Limb Ulcers on Patients With Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating TWB-103 for Diabetic Foot Ulcer. Completed, enrolled 10 participants across 2 sites.
Detailed Summary
Primary Objective: To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers Secondary Objective: To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesTaiwan
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartDec 2019
Primary CompletionJul 2021
TodayJul 2026
First PostedAug 9, 2018
Enrollment StartDec 19, 2019
Primary CompletionJul 9, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.9 years ago
Interventions
TWB-103drug
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications