Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients

A Randomized, Double-Blind Exploratory Pilot Study Comparing Prontosan(TM) Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients

This is a randomized controlled double blinded study involving two (2) investigational sites in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This is a 12-week study.

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Complications
• Intervention / Treatment: Device: Prontosan; Device: Saline

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92130
      • University of California San Diego
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female diabetic (type I or II) patients ≥ 18 years of age.
• Diabetic ulcer(s) present for ≥ 4 weeks located below the knee.
• A total surface area of ≥ 3 cm2 and ≤ 16 cm2.
• Willingness to wear an off-loading device if medically indicated (e.g., DH shoe or Walker).

Exclusion Criteria:

• Pregnant women and nursing mothers.
• Uncontrolled diabetes as defined by glucose levels >225 mg/dl.
• HbA1c ≥ 12%.
• Subjects with a wound infection.
• Subjects receiving antibiotic therapy within 14 days of enrollment.
• Subject with history of or clinical evidence of: Cardiac insufficiency (NYHA functional classification IV), angina pectoris (CCS functional classification IV), unstable pulmonary, renal, hepatic, endocrine or hematologic disease as determined by the Investigator (serum creatinine of > 3.0; transaminase or alkaline phosphatase levels equal to or greater than 5 times the upper limit) malnutrition (albumin < 2.5 g/dL).
• Peripheral arterial occlusive disease with a non-palpable pulse on both dorsal pedial and the posterior tibial artery.
• Presence of gangrene.
• Active rheumatic or collagen vascular disease (including rheumatoid arthritis, scleroderma, and systemic lupus erythematosus)
• Subjects that have been diagnosed with HBV, HVC, AIDS or are HIV positive.
• Osteomyelitis diagnosed by x-ray, bone biopsy, or other radiological procedure within 90 days prior to Screening Period.
• Active radiation therapy below the hip.
• Subject currently receiving, or has received oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents within 30 days prior to Baseline Visit (Visit 1, Week 0) or is anticipated to require such agents during the course of the study.
• Current participation or participation in another investigational drug or medical device study within the last 30 days.
• Subjects who test positive for alcohol and or illicit drug use.
• Subjects who are unable to comprehend or comply with study requirements or ability to sign an informed consent.
• Subjects, who in the opinion of the Investigator would not be a suitable candidate for this study (reason for exclusion needs to be documented).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prontosan Solution and Gel; ProntosanTM Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and ProntosanTM Wound Gel (PHMB 0.1%, Betaine 0.1%)	Device: Prontosan; Prontosan(TM) Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and Prontosan(TM) Wound Gel (PHMB 0.1%, Betaine 0.1%). Dressings will be changed and the treatment procedure will be repeated daily with 30ml/40 ml wound solution and 30 ml wound gel for a period of 12 weeks.; Other Names: Double-blind intervetion; Active/placebo comparator unknown.
Placebo Comparator: Saline Solution and Inert Gel	Device: Saline; Saline Wound Irrigation Solution and inert Wound Gel. Dressings will be changed and the treatment procedure will be repeated daily with 30ml/40 ml wound solution and 30 ml wound gel for a period of 12 weeks.; Other Names: Double-blind intervetion; Active/placebo comparator unknown.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in absolute wound area dimensions	12-week treatment period
Identification of bacteria present on wound bed at baseline and follow-up	12-week treatment period
Relative change in bacterial load during treatment period	12-week treatment period
Change in wound margins determined by color photography	12-week treatment period
Number of "non-responders" as measured by wound size change (<50% relative wound size reduction	12-week treatment period
Change of clinical wound infection during treatment period	12-week treatment period

Collaborators and Investigators

• Sponsor: B. Braun Medical Inc.
• Investigators: Principal Investigator: William Ennis, DO, University of Illinois Chicago; Principal Investigator: Gerit Mulder, DPM, University of California, San Diego

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): July 16, 2013
• Last Update Submitted That Met QC Criteria: July 15, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Cleansing; Chronic Leg Ulcers; Diabetic Patients
• Additional Relevant MeSH Terms: Skin Diseases; Endocrine System Diseases; Skin Ulcer; Diabetes Mellitus; Leg Ulcer; Diabetes Complications
• Other Study ID Numbers: OPM-I-H-0910