Diabetic Complications Clinical Trial
Official title:
A Randomized, Double-Blind Exploratory Pilot Study Comparing Prontosan(TM) Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients
| Verified date | July 2013 |
| Source | B. Braun Medical Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | October 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Illinois Chicago | Chicago | Illinois |
| United States | University of California San Diego | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| B. Braun Medical Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period | Baseline and 12 weeks | No | |
| Secondary | Change in absolute wound area dimensions | 12-week treatment period | No | |
| Secondary | Identification of bacteria present on wound bed at baseline and follow-up | 12-week treatment period | No | |
| Secondary | Relative change in bacterial load during treatment period | 12-week treatment period | No | |
| Secondary | Change in wound margins determined by color photography | 12-week treatment period | No | |
| Secondary | Number of "non-responders" as measured by wound size change (<50% relative wound size reduction | 12-week treatment period | No | |
| Secondary | Change of clinical wound infection during treatment period | 12-week treatment period | No |