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

Conditions

• Diabetic Foot Ulcers

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jan 31, 2015

Status verified

Jan 2023

Primary completion

May 31, 2015

Completion

Sep 30, 2015

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Presence of Local Skin Reactions (LSR) [ Time Frame: 84 days ]