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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

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

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

NCT ID

NCT00563433

First Posted

November 21, 2007

Last Updated

September 1, 2020

Sponsor

Abeona Therapeutics, Inc

Collaborators

Genaera Corporation

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

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

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

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

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