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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Diabetic Complications

In brief

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.

Key facts

Study ID

NCT01554644

Run by

B. Braun Medical Inc.

People needed

0

Starts

2012-03-01

Expected to finish

2012-10-01

Last updated by the study team

2013-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• University of California San Diego — San Diego, California, United States
• University of Illinois Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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