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

NCT ID: NCT02091596

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-09-30

Brief 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 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.

Conditions

Diabetic Foot Ulcer; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PluroGel

PluroGel

Group Type: PLACEBO_COMPARATOR

PluroGel

Intervention Type: DRUG

PluroGel Vehicle Placebo Comparator

PluroGel N

PluroGel N

Group Type: EXPERIMENTAL

PluroGel N

Intervention Type: DRUG

Study Drug

Interventions

PluroGel N

Study Drug

Intervention Type: DRUG

PluroGel

PluroGel Vehicle Placebo Comparator

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

• 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.

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arkios BioDevelopment International

INDUSTRY

Sponsor Role: collaborator

PluroGen Therapeutics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ledesma Foot and Ankle

Phoenix, Arizona, United States

Foot & Ankle Clinic

Los Angeles, California, United States

Samuel Merritt University

Oakland, California, United States

ASAP Urgent-Care

Hamden, Connecticut, United States

Advance Medical Research Center

Miami, Florida, United States

Miami Center for Clinical Research, LLC

Miami, Florida, United States

Unlimited Medical Research, LLC

Miami, Florida, United States

Phoenix Medical Research, LLC

Miami, Florida, United States

Med Research of Florida, LCC

Miami, Florida, United States

Sweet Hope Research Specialty, Inc.

Miami Lakes, Florida, United States

Weil Foot & Ankle Institute

Des Plaines, Illinois, United States

Research Integrity

Owensboro, Kentucky, United States

Paddington Testing Company, Inc

Philadelphia, Pennsylvania, United States

AllCare Foot & Ankle, PA

Arlington, Texas, United States

Coastal Podiatry Group

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

D11AC00020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PGN-1300

Identifier Type: -

Identifier Source: org_study_id