Trials / Completed
CompletedNCT04569409
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.
Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers: A Randomized, Comparator-controlled, Double-blind, Parallel-group, Multi-center Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Anterogen Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy.
Detailed description
Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double blind, Parallel-group, Multi-center Study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALLO-ASC-DFU | Application of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer |
| PROCEDURE | Vehicle Sheet | Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer |
Timeline
- Start date
- 2020-07-14
- Primary completion
- 2024-12-05
- Completion
- 2024-12-05
- First posted
- 2020-09-29
- Last updated
- 2025-09-22
Locations
5 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04569409. Inclusion in this directory is not an endorsement.