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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02367690




Registration number
NCT02367690
Ethics application status
Date submitted
9/02/2015
Date registered
20/02/2015

Titles & IDs
Public title
Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients
Scientific 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
Secondary ID [1] 0 0
KCP-330-501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Ulcers 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Selinexor
Other interventions - Standard-of-Care
Other interventions - Vehicle Gel

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.

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.

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.


Treatment: Drugs: Selinexor
Topical gel

Other interventions: Standard-of-Care
Surgical debridement, sterile saline rinses, and dressing changes.

Other interventions: Vehicle Gel
Topical vehicle gel with no active ingredients.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of Local Skin Reactions (LSR)
Timepoint [1] 0 0
84 days
Secondary outcome [1] 0 0
Ulcer Closure
Timepoint [1] 0 0
84 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Karyopharm Therapeutics Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02367690