Clinical trial NCT01590758: 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: 2012-05-03
Enrollment: 189
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.
2. IDSA-defined severe infection.
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 Success
timeFrame: 28 days
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE)
timeFrame: 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Fair Oaks
country: United States
state: California
city: Fresno
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Boynton Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Cambridge
country: United States
state: Massachusetts
city: Missoula
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Emerson
country: United States
state: New Jersey
city: Greenville
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Aiken
country: United States
state: South Carolina
city: Baytown
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: BioStrategics Consulting Ltd
name: Michael H. Silverman, MD
role: STUDY_DIRECTOR
References: