Diabetic Foot UlcerPhase 2NCT02119754
Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
A Phase 2 study testing Plurogel PN in people with Diabetic Foot Ulcer and Infection, run by PluroGen Therapeutics, Inc at 15 sites in United States.
Trial summary
This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Infection
- What is being tested?
- Plurogel PN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2013to Sep 2014
- Phase
- Phase 2
- 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
- Subjects who have failed treatment on Protocol PGN-1300X
Who cannot join
- -
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
AllCare Foot & Ankle, PA
Arlington, Texas, 76015
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016
ASAP Urgent-Care
Hamden, Connecticut, 06514
Foot & Ankle Clinic
Los Angeles, California, 90010
Advance Medical Research Center
Miami, Florida, 33135
Miami Center for Clinical Research, LLC
Miami, Florida, 33144
Unlimited Medical Research, LLC
Miami, Florida, 33144
Phoenix Medical Research, LLC
Miami, Florida, 33165
Med Research of Florida, LCC
Miami, Florida, 33186
Sweet Hope Research Specialty, Inc.
Miami Lakes, Florida, 33016
Samuel Merritt University
Oakland, California, 94609
Research Integrity
Owensboro, Kentucky, 42303
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, 19103
Ledesma Foot and Ankle
Phoenix, Arizona, 85032
Coastal Podiatry Group
Virginia Beach, Virginia, 23464
About this study
Official title: Open Label Trial of Topical PluroGel PN for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300X
This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.
- Conditions
- Diabetic Foot Ulcer, Infection
- Being tested
- Plurogel PN
- Keywords
- Wound, Ulcer, Infected, Infection
- Medical subject headings
- Diabetic Foot, Infections, Wounds and Injuries, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plurogel PNDrug
| Study group | Role | What they receive |
|---|---|---|
| Plurogel PN | Experimental | Plurogel PN Receives: Drug: Plurogel PN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- PluroGen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arkios BioDevelopment International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119754
- Sponsor's protocol ID
- PGN-1300X
- Other IDs
- D11AC00020
- Status last verified
- Sep 2014
- First submitted
- 17 Apr 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Trial of Topical PluroGel PN for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300X
- ClinicalTrials.gov ID
- NCT02119754
- Acronym / sponsor ID
- PGN-1300X
- Conditions
- Diabetic Foot Ulcer, Infection
- Keywords
- Wound, Ulcer, Infected, Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PluroGen Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Arkios BioDevelopment International
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Apr 2014 (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.
This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plurogel PN | Experimental | Drug: Plurogel PNPlurogel PN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who have failed treatment on Protocol PGN-1300X
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Plurogel PN | Drug | Plurogel PN |
Primary outcome
Clinical Response
Time frame: 14 days
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.
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 25 Sep 2014.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plurogel PN in people with Diabetic Foot Ulcer and Infection, run by PluroGen Therapeutics, Inc at 15 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 1 inclusion and 1 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 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinical Response (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2014.