drugset / Trial / NCT02091596
Topical PluroGel N for the Treatment of Mildly Infected Diabetic Foot Ulcers
Phase 2
Completed
42 enrolled
PluroGen Therapeutics, Inc
Arkios BioDevelopment International · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This will be a randomized, double-blind (evaluator-blind), vehicle-controlled study of 50 enrolled subjects. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone). Subjects must also provide informed consent and meet all other entry criteria to be enrolled and randomly assigned to receive PluroGel N or PluroGel vehicle.
Timeline
- Start
- 2013-10
- Primary completion
- 2014-09
- Completion
- 2014-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PluroGel N | Unknown | — | Topical |