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Diabetic Foot Ulcers

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

Sponsored by Karyopharm Therapeutics Inc

About this trial

Last updated 2 years ago

Study ID

KCP-330-501

Status

Withdrawn

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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

Locations

Location

Status