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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Complications

Intervention / Treatment
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* Device: Prontosan
* Device: Saline


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prontosan Solution and Gel<br>ProntosanTM Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and ProntosanTM Wound Gel (PHMB 0.1%, Betaine 0.1%) | Device: Prontosan<br>* 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.<br>* Other names: Double-blind intervetion; Active/placebo comparator unknown.;|
| Placebo Comparator: Saline Solution and Inert Gel<br> | Device: Saline<br>* 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.<br>* Other names: Double-blind intervetion; Active/placebo comparator unknown.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cleansing, Chronic Leg Ulcers, Diabetic Patients