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

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ClinicalTrials.gov Identifier: NCT01554644
Recruitment Status : Withdrawn (Lack of Enrollment)
First Posted : March 15, 2012
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetic Complications Device: Prontosan Device: Saline

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2012
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Double-blind intervetion; Active/placebo comparator unknown.


Outcome Measures

Primary Outcome Measures :
  1. Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Change in absolute wound area dimensions [ Time Frame: 12-week treatment period ]
  2. Identification of bacteria present on wound bed at baseline and follow-up [ Time Frame: 12-week treatment period ]
  3. Relative change in bacterial load during treatment period [ Time Frame: 12-week treatment period ]
  4. Change in wound margins determined by color photography [ Time Frame: 12-week treatment period ]
  5. Number of "non-responders" as measured by wound size change (<50% relative wound size reduction [ Time Frame: 12-week treatment period ]
  6. Change of clinical wound infection during treatment period [ Time Frame: 12-week treatment period ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554644


Locations
United States, California
University of California San Diego
San Diego, California, United States, 92130
United States, Illinois
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
B. Braun Medical Inc.
Investigators
Principal Investigator: William Ennis, DO University of Illinois Chicago
Principal Investigator: Gerit Mulder, DPM University of California, San Diego
More Information

Responsible Party: B. Braun Medical Inc.
ClinicalTrials.gov Identifier: NCT01554644     History of Changes
Other Study ID Numbers: OPM-I-H-0910
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013

Keywords provided by B. Braun Medical Inc.:
Cleansing
Chronic Leg Ulcers
Diabetic Patients

Additional relevant MeSH terms:
Leg Ulcer
Diabetes Complications
Skin Ulcer
Skin Diseases
Diabetes Mellitus
Endocrine System Diseases
Pharmaceutical Solutions