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

Primary Purpose

Diabetic Complications

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prontosan
Saline
Sponsored by
B. Braun Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Complications focused on measuring Cleansing, Chronic Leg Ulcers, Diabetic Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of California San Diego
  • University of Illinois Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prontosan Solution and Gel

Saline Solution and Inert Gel

Arm Description

ProntosanTM Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and ProntosanTM Wound Gel (PHMB 0.1%, Betaine 0.1%)

Outcomes

Primary Outcome Measures

Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period

Secondary Outcome Measures

Change in absolute wound area dimensions
Identification of bacteria present on wound bed at baseline and follow-up
Relative change in bacterial load during treatment period
Change in wound margins determined by color photography
Number of "non-responders" as measured by wound size change (<50% relative wound size reduction
Change of clinical wound infection during treatment period

Full Information

First Posted
March 6, 2012
Last Updated
July 15, 2013
Sponsor
B. Braun Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01554644
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of Enrollment
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Medical Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Complications
Keywords
Cleansing, Chronic Leg Ulcers, Diabetic Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prontosan Solution and Gel
Arm Type
Active Comparator
Arm Description
ProntosanTM Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and ProntosanTM Wound Gel (PHMB 0.1%, Betaine 0.1%)
Arm Title
Saline Solution and Inert Gel
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Prontosan
Other Intervention Name(s)
Double-blind intervetion; Active/placebo comparator unknown.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Saline
Other Intervention Name(s)
Double-blind intervetion; Active/placebo comparator unknown.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in absolute wound area dimensions
Time Frame
12-week treatment period
Title
Identification of bacteria present on wound bed at baseline and follow-up
Time Frame
12-week treatment period
Title
Relative change in bacterial load during treatment period
Time Frame
12-week treatment period
Title
Change in wound margins determined by color photography
Time Frame
12-week treatment period
Title
Number of "non-responders" as measured by wound size change (<50% relative wound size reduction
Time Frame
12-week treatment period
Title
Change of clinical wound infection during treatment period
Time Frame
12-week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Ennis, DO
Organizational Affiliation
University of Illinois Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerit Mulder, DPM
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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

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