search
Back to results

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

Primary Purpose

Diabetic Foot Ulcers

Status
Withdrawn
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
Selinexor
Standard-of-Care
Vehicle Gel
Sponsored by
Karyopharm Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Diabetes, Foot Ulcers, DFU, KPT-330, Selinexor, Karyopharm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Pacific Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

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.

Cohort 2 will be randomized to one of the following treatment groups: Standard-of-care (SOC) + Selinexor gel, 30 μM SOC + vehicle gel SOC alone.

Cohort 3 will be randomized to one of the following treatment groups: Standard-of-care (SOC) + Selinexor gel, 70 μM SOC + vehicle gel SOC alone.

Outcomes

Primary Outcome Measures

Presence of Local Skin Reactions (LSR)
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.

Secondary Outcome Measures

Ulcer Closure
Proportion of patients in each treatment group with complete ulcer closure of the target diabetic foot ulcer.

Full Information

First Posted
February 9, 2015
Last Updated
January 19, 2023
Sponsor
Karyopharm Therapeutics Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT02367690
Brief Title
Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Due to enrollment challenges & improved SOC during run-in phase; no patients received KPT-330. Withdrawal is not a consequence of any safety concern.
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karyopharm Therapeutics Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Diabetes, Foot Ulcers, DFU, KPT-330, Selinexor, Karyopharm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Cohort 2 will be randomized to one of the following treatment groups: Standard-of-care (SOC) + Selinexor gel, 30 μM SOC + vehicle gel SOC alone.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Cohort 3 will be randomized to one of the following treatment groups: Standard-of-care (SOC) + Selinexor gel, 70 μM SOC + vehicle gel SOC alone.
Intervention Type
Drug
Intervention Name(s)
Selinexor
Other Intervention Name(s)
KPT-330
Intervention Description
Topical gel
Intervention Type
Other
Intervention Name(s)
Standard-of-Care
Other Intervention Name(s)
SOC
Intervention Description
Surgical debridement, sterile saline rinses, and dressing changes.
Intervention Type
Other
Intervention Name(s)
Vehicle Gel
Intervention Description
Topical vehicle gel with no active ingredients.
Primary Outcome Measure Information:
Title
Presence of Local Skin Reactions (LSR)
Description
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.
Time Frame
84 days
Secondary Outcome Measure Information:
Title
Ulcer Closure
Description
Proportion of patients in each treatment group with complete ulcer closure of the target diabetic foot ulcer.
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
South Pacific Clinical Trials
City
Auckland
ZIP/Postal Code
0610
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs