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

NCT ID: NCT02367690

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-09-30

Brief 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.

Detailed Description

Approximately 30 patients who meet the eligibility criteria will be enrolled. Eligible patients with diabetic foot ulcers will be screened, randomized, treated, and followed for complete ulcer closure.

After screening, qualified patients will be treated for up to 12 weeks. Patients who achieve complete ulcer closure will be followed for an additional 12 weeks.

All patients will receive standard-of-care treatment. After randomization some patients will be treated with topical Selinexor gel twice weekly and some patients will be treated with a topical placebo gel twice weekly. Patients receiving Selinexor will be assigned to a sequential treatment cohort, either a 10 μM (μmol/L), 30 μM, or 70 μM dose.

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cohort 1

Cohort 1 will be randomized to one of the following treatment groups:

a) Standard-of-care (SOC) + Selinexor gel, 10 μM

, b) SOC + vehicle gel c) SOC alone.

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: DRUG

Topical gel

Standard-of-Care

Intervention Type: OTHER

Surgical debridement, sterile saline rinses, and dressing changes.

Vehicle Gel

Intervention Type: OTHER

Topical vehicle gel with no active ingredients.

Cohort 2

Cohort 2 will be randomized to one of the following treatment groups:

1. Standard-of-care (SOC) + Selinexor gel, 30 μM

2. SOC + vehicle gel

3. SOC alone.

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: DRUG

Topical gel

Standard-of-Care

Intervention Type: OTHER

Surgical debridement, sterile saline rinses, and dressing changes.

Vehicle Gel

Intervention Type: OTHER

Topical vehicle gel with no active ingredients.

Cohort 3

Cohort 3 will be randomized to one of the following treatment groups:

1. Standard-of-care (SOC) + Selinexor gel, 70 μM

2. SOC + vehicle gel

3. SOC alone.

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: DRUG

Topical gel

Standard-of-Care

Intervention Type: OTHER

Surgical debridement, sterile saline rinses, and dressing changes.

Vehicle Gel

Intervention Type: OTHER

Topical vehicle gel with no active ingredients.

Interventions

Selinexor

Topical gel

Intervention Type: DRUG

Standard-of-Care

Surgical debridement, sterile saline rinses, and dressing changes.

Intervention Type: OTHER

Vehicle Gel

Topical vehicle gel with no active ingredients.

Intervention Type: OTHER

Other Intervention Names

KPT-330; SOC

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karyopharm Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

South Pacific Clinical Trials

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

KCP-330-501

Identifier Type: -

Identifier Source: org_study_id