NCT02367690

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

February 9, 2015

Last Update Submit

January 19, 2023

Conditions

Diabetic Foot Ulcers

Keywords

DiabetesFoot UlcersDFUKPT-330SelinexorKaryopharm

Outcome Measures

Primary Outcomes (1)

  • 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.

    84 days

Secondary Outcomes (1)

  • Ulcer Closure

    84 days

Study Arms (3)

Cohort 1

EXPERIMENTAL

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: SelinexorOther: Standard-of-CareOther: Vehicle Gel

Cohort 2

EXPERIMENTAL

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: SelinexorOther: Standard-of-CareOther: Vehicle Gel

Cohort 3

EXPERIMENTAL

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: SelinexorOther: Standard-of-CareOther: Vehicle Gel

Interventions

SelinexorDRUG

Topical gel

Also known as: KPT-330
Cohort 1Cohort 2Cohort 3
Standard-of-CareOTHER

Surgical debridement, sterile saline rinses, and dressing changes.

Also known as: SOC
Cohort 1Cohort 2Cohort 3
Vehicle GelOTHER

Topical vehicle gel with no active ingredients.

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Pacific Clinical Trials

Auckland, 0610, New Zealand

Location

MeSH Terms

Conditions

Diabetic FootDiabetes MellitusFoot Ulcer

Interventions

selinexorStandard of Care

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 20, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

September 1, 2015

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Locations

NZ(1)