Diabetic Foot Ulcers
Conditions
Keywords
Diabetes, Foot Ulcers, DFU, KPT-330, Selinexor, Karyopharm
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.
Interventions
DRUGSelinexor
Topical gel
OTHERStandard-of-Care
Surgical debridement, sterile saline rinses, and dressing changes.
OTHERVehicle Gel
Topical vehicle gel with no active ingredients.
Sponsors
Karyopharm Therapeutics Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Local Skin Reactions (LSR) | 84 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Closure | 84 days | Proportion of patients in each treatment group with complete ulcer closure of the target diabetic foot ulcer. |
Countries
New Zealand
Outcome results
None listed