drugset / Trial / NCT02367690
Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients
RandomizedParallel-groupSingle-blindTreatment
Summary
Patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. This is a randomized trial. All patients will receive standard-of-care treatment. Additionally, some patients will receive treatment with topical Selinexor gel and some will receive topical placebo gel.
Timeline
- Start
- 2015-01
- Primary completion
- 2015-05
- Completion
- 2015-09
Outcome
Outcome not reported
Stopped (Enrollment): “Due to enrollment challenges \& improved SOC during run-in phase; no patients received KPT-330. Withdrawal is not a consequence of any safety concern.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selinexor | Other / unclassified | 10 unknown | Topical |
| Subject | Selinexor | Other / unclassified | 30 unknown | Topical |
| Subject | Selinexor | Other / unclassified | 70 unknown | Topical |