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

NCT ID: NCT01554644

Last Updated: 2013-07-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-10-31

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.

Conditions

Diabetic Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Prontosan Solution and Gel

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

Group Type: ACTIVE_COMPARATOR

Prontosan

Intervention Type: DEVICE

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.

Saline Solution and Inert Gel

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Ennis, DO

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Gerit Mulder, DPM

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California San Diego

San Diego, California, United States

University of Illinois Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

OPM-I-H-0910

Identifier Type: -

Identifier Source: org_study_id