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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Withdrawn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

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

NCT ID

NCT01554644

First Posted

March 6, 2012

Last Updated

July 15, 2013

Sponsor

B. Braun Medical Inc.

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

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

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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