TWB-103 for Treating Lower Limb Ulcers on Patients With DM

Status Completed

Clinical Trial 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

Clinical Trial Description

Diabetic foot ulcers are primarily caused by poor circulation, high blood sugar (hyperglycemia), nerve damage, and foot irritation or injury. These factors, particularly poor circulation and high blood sugar, often hinder the healing process of ulcers. TWB-103 is a combination of TWB-102 cells (human fetal dermal fibroblasts) and TWB-103 hydrogel. The objective of this study was to determine whether the application of TWB-103 on diabetic ulcer wounds could accelerate the healing process in subjects with diabetic lower limb ulcers that had not shown signs of healing for at least four weeks. The study was designed as a Phase I/II, single-arm trial, with a planned enrollment of 10 subjects. These subjects would receive up to 12 weekly applications of TWB-103, and the study would evaluate both the safety and efficacy of the treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03624023
Study type	Interventional
Source	Transwell Biotech Co., Ltd.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	December 19, 2019
Completion date	July 9, 2021

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See also
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