Diabetic Foot UlcersPhase 3NCT00563394
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
A Phase 3 study testing ofloxacin and MSI-78 in people with Diabetic Foot Ulcers, run by Abeona Therapeutics, Inc at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- ofloxacin and MSI-78
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1994to Jul 1996
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle VA Medical Center
Seattle, Washington, 98108-1597
About this study
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.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- ofloxacin, MSI-78
- Keywords
- diabetic, diabetes mellitus, foot, ulcers, Floxin, oral antibiotic, topical cream
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofloxacinDrug
Also called Floxin
400 mg twice a day for 14 days
MSI-78Drug
1%/2% topical cream twice a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| ofloxacin | Active comparator | 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 Receives: Drug: ofloxacin |
| MSI-78 | Active comparator | 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. Receives: Drug: MSI-78 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in clinical signs and symptoms of the infection
a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy
Measured: Study day 10
Secondary outcomes (5)
microbiological response to therapy,
Measure microbiological response to therapy
Measured: Study day 10
Wound infection score
Measure wound infection score.
Measured: Study day 10
Total wound score
Measure total wound score.
Measured: Study day 10
Wound Area
Measure wound area.
Measured: Study day 10
Wound Depth
Measure wound depth.
Measured: Study day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startAug 1994
- Primary completionJul 1996
- Study completionJul 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abeona Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genaera Corporation
- Responsible party
- Sponsor
- Investigators
- Paul Litka, MD, Study director, Magainin Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563394
- Sponsor's protocol ID
- MSI-78-303
- Status last verified
- Sep 2020
- First submitted
- 21 Nov 2007
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
- ClinicalTrials.gov ID
- NCT00563394
- Acronym / sponsor ID
- MSI-78-303
- Conditions
- Diabetic Foot Ulcers
- Keywords
- diabetic, diabetes mellitus, foot, ulcers, Floxin, oral antibiotic, topical cream
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Abeona Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Genaera Corporation
- Study start
- Aug 1994
- Primary completion
- Jul 1996 (actual)
- Study completion
- Jul 1996 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ofloxacin | Active comparator | Drug: ofloxacinan 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 |
| MSI-78 | Active comparator | Drug: MSI-78an 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ofloxacinAlso: Floxin400 mg twice a day for 14 days | Drug | ofloxacin |
| MSI-781%/2% topical cream twice a day for 14 days | Drug | MSI-78 |
Primary outcome
Reduction in clinical signs and symptoms of the infection
Time frame: Study day 10
a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy
5 secondary outcomes
microbiological response to therapy,
Time frame: Study day 10
Wound infection score
Time frame: Study day 10
Total wound score
Time frame: Study day 10
Wound Area
Time frame: Study day 10
Wound Depth
Time frame: Study day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 18990064Lipsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Litka, MD study director
Magainin Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ofloxacin and MSI-78 in people with Diabetic Foot Ulcers, run by Abeona Therapeutics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in clinical signs and symptoms of the infection (time frame: Study day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00563394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.