Clinical trial NCT02367690: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot Ulcers
Keywords: Diabetes
Foot Ulcers
DFU
KPT-330
Selinexor
Karyopharm
Lead sponsor: Karyopharm Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Presence of Local Skin Reactions (LSR)
timeFrame: 84 days
Secondary outcomes:
measure: Ulcer Closure
timeFrame: 84 days
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: South Pacific Clinical Trials
Study officials:
References: