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

NCT02091596 | Completed Phase 2

• 2 other identifiers: PGN-1300D11AC00020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 15

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

Keywords

Wound; Ulcer; Infected; Infection

Outcome Measures

Primary Outcomes (1)

• Clinical Response

  Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.

  14 Days

Study Arms (2)

PluroGel

PLACEBO COMPARATOR

PluroGel

Drug: PluroGel

PluroGel N

EXPERIMENTAL

PluroGel N

Drug: PluroGel N

Interventions

PluroGel N DRUG

Study Drug

PluroGel N

PluroGel DRUG

PluroGel Vehicle Placebo Comparator

PluroGel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• PluroGen Therapeutics, Inc: lead
• Arkios BioDevelopment International: collaborator

Study Sites (15)

Ledesma Foot and Ankle

Phoenix, Arizona, 85032, United States

Location

Foot & Ankle Clinic

Los Angeles, California, 90010, United States

Location

Samuel Merritt University

Oakland, California, 94609, United States

Location

ASAP Urgent-Care

Hamden, Connecticut, 06514, United States

Location

Advance Medical Research Center

Miami, Florida, 33135, United States

Location

Miami Center for Clinical Research, LLC

Miami, Florida, 33144, United States

Location

Unlimited Medical Research, LLC

Miami, Florida, 33144, United States

Location

Phoenix Medical Research, LLC

Miami, Florida, 33165, United States

Location

Med Research of Florida, LCC

Miami, Florida, 33186, United States

Location

Sweet Hope Research Specialty, Inc.

Miami Lakes, Florida, 33016, United States

Location

Weil Foot & Ankle Institute

Des Plaines, Illinois, 60016, United States

Location

Research Integrity

Owensboro, Kentucky, 42303, United States

Location

Paddington Testing Company, Inc

Philadelphia, Pennsylvania, 19103, United States

Location

AllCare Foot & Ankle, PA

Arlington, Texas, 76015, United States

Location

Coastal Podiatry Group

Virginia Beach, Virginia, 23464, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Infections; Wounds and Injuries; Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 19, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

US (15)