Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
Condition: Diabetic Foot Infection
MeSH terms: Infections; Communicable Diseases; Diabetic Foot; Foot Ulcer
Intervention: Topical pexiganan cream 0.8%; Topical placebo cream; Standard wound care
Intervention description: 14 days of treatment; 14 days of treatment; 14 days of treatment
Intervention MeSH terms: Pexiganan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Foot Ulcer Infection

Summary:

      The purpose of this study is to establish the clinical superiority and the safety of topical
      pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus
      standard local wound care, in the treatment of mildly infected diabetic foot ulcers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diabetes mellitus.

          2. Male or female at least 18 years old.

          3. Subject must agree to adhere to all protocol procedures and return for all scheduled
             visits, and must be willing and able to provide written informed consent.

          4. Subject is to be treated on an outpatient basis.

          5. Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli
             with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.

          6. Localized mild infection of the ulcer.

          7. The diagnosis of mild infection must be confirmed immediately following debridement at
             Baseline.

          8. Subject must have plain radiographs taken within 2 days prior to entry showing no
             evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with
             tissue crepitus, in the affected foot.

        Exclusion Criteria:

          1. IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis;
             spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone
             involvement.

          2. IDSA-defined severe infection, including systemic toxicity or metabolic instability.

          3. Infected diabetic foot ulcer that is associated with local wound complications such as
             prosthetic materials or protruding surgical hardware.

          4. > 1 infected foot ulcer.

          5. Subject is currently receiving topical antimicrobial treatment for a localized
             infection of the study ulcer and whose infection is improving in response to
             treatment.

          6. Subject has received a systemic antibiotic within 48 hours prior to Screening.

          7. Concurrent or expected to require systemic antimicrobials during the study period for
             any infection, including diabetic foot ulcer.

          8. Bone or joint involvement is suspected based on clinical examination or plain X-ray.

          9. Clinically significant peripheral arterial disease requiring vascular intervention.

         10. Subject is expected to be unable to care for the ulcer or return for all scheduled
             visits because of hospitalization, vacation, disability, etc. during the study period,
             or is unable to safely monitor the infection status at home.