NCT01590758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
Last Updated

June 14, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

April 27, 2012

Results QC Date

April 14, 2017

Last Update Submit

May 19, 2017

Conditions

Diabetic Foot Infection

Keywords

Diabetic Foot Ulcer Infection

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clinical Response

    The numbers of participants with Clinical Response, defined as resolution of infection, are reported.

    28 days

Secondary Outcomes (2)

  • Number of Participants With Microbiological Success

    28 days

  • Number of Participants With Treatment-emergent Adverse Events (TEAE)

    28 days

Study Arms (2)

Topical placebo control

PLACEBO COMPARATOR
Drug: Topical placebo creamOther: Standard wound care

Topical pexiganan cream 0.8%

EXPERIMENTAL
Drug: Topical pexiganan cream 0.8%Other: Standard wound care

Interventions

Topical pexiganan cream 0.8%DRUG

14 days of treatment

Also known as: MSI-78
Topical pexiganan cream 0.8%
Topical placebo creamDRUG

14 days of treatment

Topical placebo control
Standard wound careOTHER

14 days of treatment

Topical pexiganan cream 0.8%Topical placebo control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus.
  • Male or female at least 18 years old.
  • 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.
  • Subject is to be treated on an outpatient basis.
  • 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.
  • Localized mild infection of the ulcer.
  • The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
  • 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.

You may not qualify if:

  • IDSA-defined moderate infection.
  • IDSA-defined severe infection.
  • Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
  • \> 1 infected foot ulcer.
  • Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
  • Subject has received a systemic antibiotic within 48 hours prior to Screening.
  • Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
  • Bone or joint involvement is suspected based on clinical examination or plain X-ray.
  • Clinically significant peripheral arterial disease requiring vascular intervention.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Glendale, Arizona, United States

Location

Unknown Facility

Mesa, Arizona, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Jonesboro, Arkansas, United States

Location

Unknown Facility

Bakersfield, California, United States

Location

Unknown Facility

Fair Oaks, California, United States

Location

Unknown Facility

Fresno, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Boynton Beach, Florida, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

North Miami Beach, Florida, United States

Location

Unknown Facility

South Miami, Florida, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Cambridge, Massachusetts, United States

Location

Unknown Facility

Missoula, Montana, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Emerson, New Jersey, United States

Location

Unknown Facility

Greenville, North Carolina, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Aiken, South Carolina, United States

Location

Unknown Facility

Baytown, Texas, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

McAllen, Texas, United States

Location

Unknown Facility

McKinney, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Interventions

pexiganan

Results Point of Contact

Title
Robert J DeLuccia
Organization
Dipexium Pharmaceuticals, Inc
delucciarj@gmail.com
+19145226503

Study Officials

  • Michael H. Silverman, MD

    BioStrategics Consulting Ltd

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2012

First Posted

May 3, 2012

Study Start

June 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

June 14, 2017

Results First Posted

June 14, 2017

Record last verified: 2017-04

Locations

US(30)