Diabetic Foot InfectionPhase 3OneStep-2NCT01594762
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
A Phase 3 study testing Topical pexiganan cream 0.8% and Standard wound care in people with Diabetic Foot Infection, run by Dipexium Pharmaceuticals, Inc. at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infection
- What is being tested?
- Topical pexiganan cream 0.8% and Standard wound care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 39 sitesUnited States
- Study dates
- Jun 2014to Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
Who cannot join
- IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
- IDSA-defined severe infection, including systemic toxicity or metabolic instability.
- 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.
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- 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.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Study site
Castro Valley, California
Study site
Charlotte, North Carolina
Study site
Columbia, South Carolina
Study site
Coral Gables, Florida
Study site
Davis, California
Study site
Doral, Florida
Study site
Duncansville, Pennsylvania
Study site
El Paso, Texas
Study site
Evans, Georgia
Study site
Fort Worth, Texas
Study site
Hialeah, Florida
Study site
Homestead, Florida
Study site
Hutchinson, Kansas
Study site
Jacksonville, Florida
Study site
Jonesboro, Arkansas
Study site
Largo, Florida
Study site
Lewisville, Texas
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Miami Lakes, Florida
Study site
Miami Shores, Florida
Study site
Mineola, New York
Study site
Napa, California
Study site
New Orleans, Louisiana
Study site
North Chicago, Illinois
Study site
Norwalk, Connecticut
Study site
Phoenix, Arizona
Study site
Pinellas Park, Florida
Study site
Richland, Washington
Study site
Roanoke, Virginia
Study site
Salt Lake City, Utah
Study site
San Francisco, California
Study site
Santa Rosa, California
Study site
St. George, Utah
Study site
Sylmar, California
Study site
Tucson, Arizona
Study site
Vacaville, California
Study site
Wilmington, North Carolina
Study site
York, Pennsylvania
About this study
Official title: A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers
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.
- Conditions
- Diabetic Foot Infection
- Being tested
- Topical pexiganan cream 0.8%, Topical placebo cream, Standard wound care
- Keywords
- Diabetic Foot Ulcer Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical pexiganan cream 0.8%Drug
Also called MSI-78
14 days of treatment
Topical placebo creamDrug
14 days of treatment
Standard wound careOther
14 days of treatment
| Study group | Role | What they receive |
|---|---|---|
| Topical placebo control | Placebo comparator | Drug: Topical placebo cream Receives: Drug: Topical placebo cream; Other: Standard wound care |
| Topical pexiganan cream 0.8% | Experimental | Drug: Topical pexiganan cream 0.8% Receives: Drug: Topical pexiganan cream 0.8%; Other: Standard wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Response
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
Measured: 28 days
Secondary outcomes (2)
Number of Participants With Microbiological Response
The numbers of participants with Microbiological Response, defined are eradication of all baseline pathogens, are reported.
Measured: 28 days
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
The number of participants with TEAEs, including Serious TEAEs, are reported
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot InfectionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dipexium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H. Silverman, MD, Study director, Biostrategics Consulting Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594762
- Sponsor's protocol ID
- DPX-306
- Acronym
- OneStep-2
- Status last verified
- Apr 2017
- First submitted
- 7 May 2012
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
You Y, Liu H, Zhu Y, Zheng H. Rational design of stapled antimicrobial peptides. Amino Acids. 2023 Apr;55(4):421-442. doi: 10.1007/s00726-023-03245-w. Epub 2023 Feb 12.
PubMed 36781451
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01594762
- Acronym / sponsor ID
- OneStep-2 / DPX-306
- Conditions
- Diabetic Foot Infection
- Keywords
- Diabetic Foot Ulcer Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dipexium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical placebo control | Placebo comparator | Drug: Topical placebo cream, Other: Standard wound careDrug: Topical placebo cream |
| Topical pexiganan cream 0.8% | Experimental | Drug: Topical pexiganan cream 0.8%, Other: Standard wound careDrug: Topical pexiganan cream 0.8% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
- IDSA-defined severe infection, including systemic toxicity or metabolic instability.
- 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.
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 |
|---|---|---|
| Topical pexiganan cream 0.8%Also: MSI-7814 days of treatment | Drug | Topical pexiganan cream 0.8% |
| Topical placebo cream14 days of treatment | Drug | Topical placebo control |
| Standard wound care14 days of treatment | Other | Topical pexiganan cream 0.8%, Topical placebo control |
Primary outcome
Number of Participants With Clinical Response
Time frame: 28 days
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
2 secondary outcomes
Number of Participants With Microbiological Response
Time frame: 28 days
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36781451You Y, Liu H, Zhu Y, Zheng H. Rational design of stapled antimicrobial peptides. Amino Acids. 2023 Apr;55(4):421-442. doi: 10.1007/s00726-023-03245-w. Epub 2023 Feb 12.
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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.
Michael H. Silverman, MD study director
Biostrategics Consulting Ltd
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical pexiganan cream 0.8% and Standard wound care in people with Diabetic Foot Infection, run by Dipexium Pharmaceuticals, Inc. at 39 sites 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 8 inclusion and 10 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Clinical Response (time frame: 28 days). 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 NCT01594762, 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 14 Jun 2017.