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

Diabetic Foot Ulcers Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02367690
• Other study ID #: KCP-330-501
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2023
• Source: Karyopharm Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Selinexor
Topical gel

Other:
• Standard-of-Care
Surgical debridement, sterile saline rinses, and dressing changes.
• Vehicle Gel
Topical vehicle gel with no active ingredients.

Locations

Country	Name	City	State
New Zealand	South Pacific Clinical Trials	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Karyopharm Therapeutics Inc

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ulcer Closure	Proportion of patients in each treatment group with complete ulcer closure of the target diabetic foot ulcer.	84 days