Clinical trial NCT01594762: Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
Official title: A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Foot Infection
Keywords: Diabetic Foot Ulcer Infection
Lead sponsor: Dipexium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Participants With Clinical Response
timeFrame: 28 days
Secondary outcomes:
measure: Number of Participants With Microbiological Response
timeFrame: 28 days
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: 28 days
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Castro Valley
country: United States
state: California
city: Davis
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Napa
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Vacaville
country: United States
state: California
city: Norwalk
country: United States
state: Connecticut
city: Coral Gables
country: United States
state: Florida
city: Doral
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Homestead
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Miami Lakes
country: United States
state: Florida
city: Miami Shores
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Evans
country: United States
state: Georgia
city: North Chicago
country: United States
state: Illinois
city: Hutchinson
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Mineola
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Duncansville
country: United States
state: Pennsylvania
city: York
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Lewisville
country: United States
state: Texas
city: Saint George
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Roanoke
country: United States
state: Virginia
city: Richland
country: United States
state: Washington
Study officials:
affiliation: Biostrategics Consulting Ltd
name: Michael H. Silverman, MD
role: STUDY_DIRECTOR
References: