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

NCT01554644 | Withdrawn

• 1 other identifier: OPM-I-H-0910
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

Cleansing; Chronic Leg Ulcers; Diabetic Patients

Outcome Measures

Primary Outcomes (1)

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

  Baseline and 12 weeks

Secondary Outcomes (6)

• Change in absolute wound area dimensions

  12-week treatment period

• Identification of bacteria present on wound bed at baseline and follow-up

  12-week treatment period

• Relative change in bacterial load during treatment period

  12-week treatment period

• Change in wound margins determined by color photography

  12-week treatment period

• Number of "non-responders" as measured by wound size change (<50% relative wound size reduction

  12-week treatment period

Study Arms (2)

Prontosan Solution and Gel

ACTIVE COMPARATOR

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

Device: Prontosan

Saline Solution and Inert Gel

PLACEBO COMPARATOR

Device: Saline

Interventions

Prontosan 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.

Also known as: Double-blind intervetion; Active/placebo comparator unknown.

Prontosan Solution and Gel

Saline 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.

Also known as: Double-blind intervetion; Active/placebo comparator unknown.

Saline Solution and Inert Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• B. Braun Medical Inc.: lead

Study Sites (2)

University of California San Diego

San Diego, California, 92130, United States

Location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Study Officials

• William Ennis, DO

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

• Gerit Mulder, DPM

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 15, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

US (2)