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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04497805` - Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers	Phase 2
Withdrawn	`NCT03675269` - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:	N/A
Completed	`NCT04624516` - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence	N/A
Not yet recruiting	`NCT06439667` - VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Recruiting	`NCT05608187` - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers	Phase 2
Not yet recruiting	`NCT06437028` - Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.	N/A
Not yet recruiting	`NCT06278935` - Lifestyle Tailored Offloading for Diabetic Foot Ulcers	N/A
Withdrawn	`NCT05024656` - AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers	N/A
Terminated	`NCT02202668` - Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers	N/A
Completed	`NCT01951768` - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection	Phase 4
Terminated	`NCT01966380` - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia	Phase 2
Completed	`NCT01657474` - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers	N/A
Active, not recruiting	`NCT00389636` - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers	N/A
Completed	`NCT01181440` - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers	Phase 3
Enrolling by invitation	`NCT05888259` - Plantar Pressure Distribution in Diabetic Foot Ulcer	N/A
Completed	`NCT04054804` - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting	`NCT05877378` - Efficacy of PICO Single-use System in Chronic Ulcers	N/A
Recruiting	`NCT06037369` - The Short Message-based Customized Standardized	N/A
Completed	`NCT03312595` - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)	N/A
Recruiting	`NCT04564443` - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot	N/A