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

January 19, 2023 updated by: Karyopharm Therapeutics Inc

Phase 1/2, Multi-Dose, Evaluator-Blinded, Randomized, Vehicle & Standard Of Care-Controlled Dose-Escalation Study To Assess Safety, Tolerability, Pharmacokinetics Of Topical Selinexor In Patients With Diabetic Foot Ulcers

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand, 0610
        • South Pacific Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Selinexor
Topical gel
Other Names:
  • KPT-330
Other: Standard-of-Care
Surgical debridement, sterile saline rinses, and dressing changes.
Other Names:
  • SOC
Other: Vehicle Gel
Topical vehicle gel with no active ingredients.
Experimental: 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.
Drug: Selinexor
Topical gel
Other Names:
  • KPT-330
Other: Standard-of-Care
Surgical debridement, sterile saline rinses, and dressing changes.
Other Names:
  • SOC
Other: Vehicle Gel
Topical vehicle gel with no active ingredients.
Experimental: 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.
Drug: Selinexor
Topical gel
Other Names:
  • KPT-330
Other: Standard-of-Care
Surgical debridement, sterile saline rinses, and dressing changes.
Other Names:
  • SOC
Other: Vehicle Gel
Topical vehicle gel with no active ingredients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Local Skin Reactions (LSR)
Time Frame: 84 days
Presence of local skin reactions (erythema, edema, pain, tenderness, induration, swelling, wound drainage, purulence, odor, cellulitis, callus, and maceration) within 4 cm of the diabetic foot ulcer wound edge.
84 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ulcer Closure
Time Frame: 84 days
Proportion of patients in each treatment group with complete ulcer closure of the target diabetic foot ulcer.
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karyopharm Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCP-330-501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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