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

Sponsor

PluroGen Therapeutics, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT02091596

Collaborator

Arkios BioDevelopment International (Industry)

Enrollment

Locations

Arms

Duration (Months)

2.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer Infection	Drug: PluroGel N Drug: PluroGel	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: PluroGel PluroGel	Drug: PluroGel PluroGel Vehicle Placebo Comparator
Experimental: PluroGel N PluroGel N	Drug: PluroGel N Study Drug

Arm

Intervention/Treatment

Placebo Comparator: PluroGel

PluroGel

Drug: PluroGel

PluroGel Vehicle Placebo Comparator

Experimental: PluroGel N

PluroGel N

Drug: PluroGel N

Study Drug

Outcome Measures

Primary Outcome Measures

Clinical Response [14 Days]
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ledesma Foot and Ankle	Phoenix	Arizona	United States	85032
2	Foot & Ankle Clinic	Los Angeles	California	United States	90010
3	Samuel Merritt University	Oakland	California	United States	94609
4	ASAP Urgent-Care	Hamden	Connecticut	United States	06514
5	Sweet Hope Research Specialty, Inc.	Miami Lakes	Florida	United States	33016
6	Advance Medical Research Center	Miami	Florida	United States	33135
7	Miami Center for Clinical Research, LLC	Miami	Florida	United States	33144
8	Unlimited Medical Research, LLC	Miami	Florida	United States	33144
9	Phoenix Medical Research, LLC	Miami	Florida	United States	33165
10	Med Research of Florida, LCC	Miami	Florida	United States	33186
11	Weil Foot & Ankle Institute	Des Plaines	Illinois	United States	60016
12	Research Integrity	Owensboro	Kentucky	United States	42303
13	Paddington Testing Company, Inc	Philadelphia	Pennsylvania	United States	19103
14	AllCare Foot & Ankle, PA	Arlington	Texas	United States	76015
15	Coastal Podiatry Group	Virginia Beach	Virginia	United States	23464