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Diabetic Foot UlcerPhase 2NCT02091596

Topical PluroGel N for the Treatment of Mildly Infected Diabetic Foot Ulcers

A Phase 2 study testing PluroGel N and PluroGel in people with Diabetic Foot Ulcer and Infection, run by PluroGen Therapeutics, Inc at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a randomized, double-blind (evaluator-blind), vehicle-controlled study of 50 enrolled subjects. 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… 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 N and PluroGel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 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

  • Non-hospitalized subjects with Type 1 or Type 2 diabetes mellitus as defined by the American Diabetes Association diagnostic criteria (ADA, 2010). Diabetes may be treated with insulin, oral hypoglycemic agents, diet, or a combination of these therapies. Subjects whose diabetes is considered "controlled" by diet or medication in the opinion of the physician.
  • Males or females at least 18 years old.
  • Subjects must be considered by the investigator to be reliable, willing and able to give signed informed consent, and must sign the informed consent form.
  • Subjects must have a full thickness (i.e., extending through dermis but not involving tendon, bone, or joint capsule) ulcer on the foot distal to the malleoli with a surface area ≥1 cm2 after the wound has undergone appropriate debridement. Subjects must have localized mild infection of the ulcer, as defined by the IDSA criteria as per Appendix C, with in the PGN1300 Protocol, which the investigator believes would ordinarily be treated on an outpatient basis.
  • IDSA mild infection of an ulcer is defined as:
  • The presence of ≥2 of the following items:
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  • Local swelling or induration
  • Erythema
  • Local tenderness or pain
  • Local warmth
  • Purulent discharge (thick, opaque to white or sanguineous secretion) Local infection involving only the skin and the subcutaneous tissue. If erythema, must be >0.5 cm to ≤2 cm around the ulcer.
  • Diabetic Foot Infection-General Parameters Score of at least 2 must be obtained in order to be eligible for enrollment.
  • Diabetic Foot Infection-Wound Size Score of at least 1 must be obtained in order to be eligible for enrollment.
  • The diagnosis of mild infection must be confirmed immediately following the Day 0 (Enrollment Visit) debridement, although pre-debridement purulence is to be counted as one manifestation of infection.

Who cannot join

  • Subjects with IDSA-defined moderate infection as per Appendix C, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; osteomyelitis; gangrene; muscle, joint, or bone involvement.
  • Subjects with IDSA-defined severe infection as per Appendix C, within PGN1300 Protocol including systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, hyperglycemia, or azotemia).
  • Subjects with systemic inflammatory response signs, as manifested by ≥2 of the following :
  • Temperature >38°C or <36°C
  • Heart rate >90 beats/min
  • Respiratory rate >20 breaths/min or PaCO2 <32 mm Hg
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  • White blood cell count >12 000 or <4000 cells/μL or ≥10% immature (band) forms
  • Subjects with local wound complications (e.g., prosthetic materials).
  • Subjects currently receiving antibiotic treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
  • Subjects requiring concurrent systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
  • Subjects in whom bone or joint involvement is suspected based on clinical examination (e.g., bone noted visually or by probing) or plain view X-ray.
  • Subjects with clinically significant peripheral arterial disease requiring vascular reconstructive surgery. Subjects who are expected to be unable to care for their ulcer because of hospitalization, vacation, disability, etc. during the study period, or are unable to safely monitor the infection status at home.
  • Subjects with known active alcohol or substance abuse within the 6 months preceding study entry.
  • Subjects who are receiving immunosuppressive agents (other than corticosteroids), radiation therapy, or cytotoxic agents.
  • Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).
  • Subjects with a systemically immunocompromising disease, such as acquired immune deficiency syndrome or known human immunodeficiency virus infection.
  • Subjects who have had an unexplained fever or chills during the week prior to enrollment.
  • Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
  • Subjects with any known allergy or other contraindication to any ingredients in the study products.
  • Women who are breast feeding, pregnant, or not using contraception unless sterile.
  • Subjects who have been taking or expect to be taking any other investigational therapy within the 30 days prior to entry or during enrollment.

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

Other trials in United States

About this study

Official title: Randomized, Double-blind, Vehicle-controlled 2-Arm Trial of Topical PluroGel N for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300

This will be a randomized, double-blind (evaluator-blind), vehicle-controlled study of 50 enrolled subjects. 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). Subjects must also provide informed consent and meet all other entry criteria to be enrolled and randomly assigned to receive PluroGel N or PluroGel vehicle.

Being tested
PluroGel N, PluroGel
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 NDrug

    Study Drug

  • PluroGelDrug

    PluroGel Vehicle Placebo Comparator

Study groups in NCT02091596
Study groupRoleWhat they receive
PluroGelPlacebo comparatorPluroGel
Receives: Drug: PluroGel
PluroGel NExperimentalPluroGel N
Receives: Drug: PluroGel N

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted19 Mar 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02091596
Sponsor's protocol ID
PGN-1300
Other IDs
D11AC00020
Status last verified
Sep 2014
First submitted
12 Mar 2014
Last updated
25 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PluroGel N and PluroGel 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 14 inclusion and 21 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. 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 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?

On the ClinicalTrials.gov record for NCT02091596.

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.

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