drugset / Trial / NCT01421966
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Phase 3
Completed
285 enrolled
Macrocure Ltd.
ARANZ Medical · collabAmarex Clinical Research · collabICON plc · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 280 patients will be randomized to receive either CureXcell® or sham.
Timeline
- Start
- 2011-08
- Primary completion
- 2015-02
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CureXcell® | Cell therapy | — | Other |