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

• Status: Withdrawn
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karyopharm Therapeutics Inc; Karyopharm Therapeutics, Inc

Criteria

Inclusion Criteria:

• Patient has a clinical diagnosis of Type I or Type II diabetes mellitus with an HbA1c ≤ 10.0 and has a BMI ≤40.

• The DFU(s) to be treated must be:

• Anatomically discrete,

• Non-healing, but has persisted for ≤12 months

• Measures 1 cm2 ≤ area ≤ 5 cm2 following debridement,

• Has a Wagner Grade 1 (i.e., not involving bone, muscle, tendons, or ligaments),

• The Target DFU is located distal to the ankle (i.e., below the malleolus), and

• Is able to be adequately off-loaded.

• The patient has adequate arterial blood supply in the affected limb at screening.

• Patient has the inability to perceive 10 grams pressure in the peri-ulcer area and other regions of the affected foot and toes using Semmes-Weinstein 5.07 monofilament at screening.

Exclusion Criteria:

• Patient has a foot ulcer that is clearly of non-diabetic pathophysiology.

• Patient has more than two (2) DFUs on the target lower extremity.

• DFU is clinically infected.

• Patient has active osteomyelitis of the foot or active, uncontrolled, connective tissue disease