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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02367690
Ethics application status
Date submitted
9/02/2015
Date registered
20/02/2015
Date last updated
24/03/2016

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:
Standard-of-care (SOC) + Selinexor gel, 30 µM
SOC + vehicle gel
SOC alone.

Experimental: Cohort 3 - 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.


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) - 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.
Timepoint [1] 0 0
84 days
Secondary outcome [1] 0 0
Ulcer Closure - Proportion of patients in each treatment group with complete ulcer closure of the target diabetic foot ulcer.
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
Gender
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/Phase 2
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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 website
https://clinicaltrials.gov/show/NCT02367690
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Kauffman, MD, PhD
Address 0 0
Karyopharm Therapeutics Inc
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02367690