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Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients

NCT02367690 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-01-20

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcers

Interventions

DRUG

Selinexor

Topical gel

OTHER

Standard-of-Care

Surgical debridement, sterile saline rinses, and dressing changes.

OTHER

Vehicle Gel

Topical vehicle gel with no active ingredients.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-05-31
Completion
2015-09-30

Countries

  • New Zealand

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367690 on ClinicalTrials.gov