Trials / Completed
CompletedNCT03754465
Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers
A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Anterogen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.
Detailed description
1. Active Group: ALLO-ASC-SHEET 2. Control Group: Hydrogel SHEET (vehicle control) 3. Study Type: Interventional 4. Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALLO-ASC-DFU | Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer |
| PROCEDURE | Hydrogel SHEET(Vehicle control) | Application of Hydrogel SHEET to diabetic foot ulcer |
Timeline
- Start date
- 2019-01-02
- Primary completion
- 2023-10-23
- Completion
- 2023-10-23
- First posted
- 2018-11-27
- Last updated
- 2025-01-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03754465. Inclusion in this directory is not an endorsement.