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MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

Primary Purpose

Diabetic Foot Ulcers

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ofloxacin
MSI-78
Sponsored by
Abeona Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring diabetic, diabetes mellitus, foot, ulcers, Floxin, oral antibiotic, topical cream

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-hospitalized ambulatory patients with diabetes mellitus
  • Men or Women greater than 18 years old
  • Patients must be considered reliable, willing and able to give consent
  • Female patients must be postmenopausal for a least 6 months or surgically sterilized
  • Localized infection of the ulcer that would ordinarily be treated on an outpatient basis
  • Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected
  • Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis
  • Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot
  • Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry

Exclusion Criteria:

  • Patients requiring concurrent local or systemic antimicrobials during the study period for other infections
  • Patients who are currently treated or awaiting dialysis
  • Patients who are unable to care for their ulcers
  • Patients with known alcohol or substance abuse within 6 months or study entry
  • Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin
  • Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents
  • Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease.
  • Previous enrollment in this study or previous treatment with MSI-78 Topical Cream
  • Patients with gangrene or severely impaired arterial supply to any portion of the affected foot
  • Other conditions considered by the investigator to be sound reason for disqualification
  • Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream
  • Women who are breast feeding, pregnant or attempting to become pregnant

Sites / Locations

  • Seattle VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ofloxacin

MSI-78

Arm Description

an oral antibiotic (ofloxacin 400 mg) twice a day and a placebo vehicle topical cream twice a day for 14 days, extended up to 28 days if clinically warranted

an oral placebo twice a day and MSI-78 1%/2% Topical Cream twice a day for 14 days, extended up to 28 days if clinically warranted.

Outcomes

Primary Outcome Measures

Reduction in clinical signs and symptoms of infection
Measure will be a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy

Secondary Outcome Measures

Microbiological response
Measure microbiological response to therapy
Wound infection score
Measure wound infection score
Total wound score
Measure total wound score
Wound area
Measure wound area.
Wound depth.
Measure wound depth.

Full Information

First Posted
November 21, 2007
Last Updated
September 1, 2020
Sponsor
Abeona Therapeutics, Inc
Collaborators
Genaera Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00563433
Brief Title
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
Official Title
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 1994 (Actual)
Primary Completion Date
July 1996 (Actual)
Study Completion Date
July 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abeona Therapeutics, Inc
Collaborators
Genaera Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.
Detailed Description
Approximately 224 adults will be enrolled in an outpatient Phase III study to compare the safety and efficacy of topically applied magainin peptide (MSI-78) to that of ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic, in the treatment of infected diabetic foot ulcers. This is a randomized, controlled, double-blind trial that will involve twenty or more clinical centers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
diabetic, diabetes mellitus, foot, ulcers, Floxin, oral antibiotic, topical cream

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ofloxacin
Arm Type
Active Comparator
Arm Description
an oral antibiotic (ofloxacin 400 mg) twice a day and a placebo vehicle topical cream twice a day for 14 days, extended up to 28 days if clinically warranted
Arm Title
MSI-78
Arm Type
Active Comparator
Arm Description
an oral placebo twice a day and MSI-78 1%/2% Topical Cream twice a day for 14 days, extended up to 28 days if clinically warranted.
Intervention Type
Drug
Intervention Name(s)
ofloxacin
Other Intervention Name(s)
Floxin
Intervention Description
400 mg twice a day for 14 days
Intervention Type
Drug
Intervention Name(s)
MSI-78
Intervention Description
1%/2% topical cream twice a day for 14 days
Primary Outcome Measure Information:
Title
Reduction in clinical signs and symptoms of infection
Description
Measure will be a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy
Time Frame
Study day 10
Secondary Outcome Measure Information:
Title
Microbiological response
Description
Measure microbiological response to therapy
Time Frame
Study day 10
Title
Wound infection score
Description
Measure wound infection score
Time Frame
Study day 10
Title
Total wound score
Description
Measure total wound score
Time Frame
Study day 10
Title
Wound area
Description
Measure wound area.
Time Frame
Study day 10
Title
Wound depth.
Description
Measure wound depth.
Time Frame
Study day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-hospitalized ambulatory patients with diabetes mellitus Men or Women greater than 18 years old Patients must be considered reliable, willing and able to give consent Female patients must be postmenopausal for a least 6 months or surgically sterilized Localized infection of the ulcer that would ordinarily be treated on an outpatient basis Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry Exclusion Criteria: Patients requiring concurrent local or systemic antimicrobials during the study period for other infections Patients who are currently treated or awaiting dialysis Patients who are unable to care for their ulcers Patients with known alcohol or substance abuse within 6 months or study entry Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease. Previous enrollment in this study or previous treatment with MSI-78 Topical Cream Patients with gangrene or severely impaired arterial supply to any portion of the affected foot Other conditions considered by the investigator to be sound reason for disqualification Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream Women who are breast feeding, pregnant or attempting to become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Litka, MD
Organizational Affiliation
Magainin Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Seattle VA Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1597
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18990064
Citation
Lipsky BA, Holroyd KJ, Zasloff M. Topical versus systemic antimicrobial therapy for treating mildly infected diabetic foot ulcers: a randomized, controlled, double-blinded, multicenter trial of pexiganan cream. Clin Infect Dis. 2008 Dec 15;47(12):1537-45. doi: 10.1086/593185.
Results Reference
derived

Learn more about this trial

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

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