Clinical trial NCT01554644: Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients
Official title: A Randomized, Double-Blind Exploratory Pilot Study Comparing Prontosan(TM) Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Complications
Keywords: Cleansing
Chronic Leg Ulcers
Diabetic Patients
Lead sponsor: B. Braun Medical Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in absolute wound area dimensions
timeFrame: 12-week treatment period
measure: Identification of bacteria present on wound bed at baseline and follow-up
timeFrame: 12-week treatment period
measure: Relative change in bacterial load during treatment period
timeFrame: 12-week treatment period
measure: Change in wound margins determined by color photography
timeFrame: 12-week treatment period
measure: Number of "non-responders" as measured by wound size change (<50% relative wound size reduction
timeFrame: 12-week treatment period
measure: Change of clinical wound infection during treatment period
timeFrame: 12-week treatment period
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: William Ennis, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Gerit Mulder, DPM
role: PRINCIPAL_INVESTIGATOR
References: