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CompletedNCT00563433Updated Sep 3, 2020

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

A Phase 3 interventional study of ofloxacin and MSI-78 in Diabetic Foot Ulcers, sponsored by Abeona Therapeutics, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Abeona Therapeutics, Inc · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 13 years 3 months after the study started (first participant enrolled Aug 1994, registered Nov 2007).
Phase
Phase 3
Study type
Interventional
Enrollment
342
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Foot Ulcers

Keywords

  • diabetic
  • diabetes mellitus
  • foot
  • ulcers
  • Floxin
  • oral antibiotic
  • topical cream
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 342 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Abeona Therapeutics, Inc is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
342 participants (actual)

Study arms

  • Active comparator
    ofloxacin

    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

    Drug: ofloxacin

  • Active comparator
    MSI-78

    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.

    Drug: MSI-78

Interventions

  • Drugofloxacin

    400 mg twice a day for 14 days

    Also known as: Floxin

  • DrugMSI-78

    1%/2% topical cream twice a day for 14 days

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Study day 10

Secondary outcomes

  1. Microbiological response

    Measure microbiological response to therapy

    Time frame: Study day 10

  2. Wound infection score

    Measure wound infection score

    Time frame: Study day 10

  3. Total wound score

    Measure total wound score

    Time frame: Study day 10

  4. Wound area

    Measure wound area.

    Time frame: Study day 10

  5. Wound depth.

    Measure wound depth.

    Time frame: Study day 10

07

Study locations

1 site
  • Seattle VA Medical Center
    Seattle, Washington 98108-1597, United States
08

References and documents

Publications

  • 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. PubMed 18990064 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00563433
Lead sponsor
Abeona Therapeutics, Inc
Collaborators
Genaera Corporation
Responsible party
Sponsor
First posted
Nov 26, 2007
Start date
Aug 1994
Primary completion
Jul 1996
Completion
Jul 1996
Last update
Sep 3, 2020

Study contacts

Paul Litka, MD
study director · Magainin Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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