Diabetic ComplicationsNCT01554644
Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients
A study testing Prontosan and Saline in people with Diabetic Complications, run by B. Braun Medical Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Complications
- What is being tested?
- Prontosan and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois Chicago
Chicago, Illinois, 60612
University of California San Diego
San Diego, California, 92130
About this study
Official title: A Randomized, Double-Blind Exploratory Pilot Study Comparing Prontosan(TM) Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients
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
- Being tested
- Prontosan, Saline
- Keywords
- Cleansing, Chronic Leg Ulcers, Diabetic Patients
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProntosanDevice
Also called Double-blind intervetion; Active/placebo comparator unknown.
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.
SalineDevice
Also called Double-blind intervetion; Active/placebo comparator unknown.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%) Receives: Device: Prontosan |
| Saline Solution and Inert Gel | Placebo comparator | Not described Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Change in absolute wound area dimensions
Measured: 12-week treatment period
Identification of bacteria present on wound bed at baseline and follow-up
Measured: 12-week treatment period
Relative change in bacterial load during treatment period
Measured: 12-week treatment period
Change in wound margins determined by color photography
Measured: 12-week treatment period
Number of "non-responders" as measured by wound size change (<50% relative wound size reduction
Measured: 12-week treatment period
Change of clinical wound infection during treatment period
Measured: 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: Lack of Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Ennis, DO, Principal investigator, University of Illinois ChicagoGerit Mulder, DPM, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554644
- Sponsor's protocol ID
- OPM-I-H-0910
- Status last verified
- Jul 2013
- First submitted
- 6 Mar 2012
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Exploratory Pilot Study Comparing Prontosan(TM) Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01554644
- Acronym / sponsor ID
- OPM-I-H-0910
- Conditions
- Diabetic Complications
- Keywords
- Cleansing, Chronic Leg Ulcers, Diabetic Patients
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- B. Braun Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prontosan Solution and Gel | Active comparator | Device: ProntosanProntosanTM Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and ProntosanTM Wound Gel (PHMB 0.1%, Betaine 0.1%) |
| Saline Solution and Inert Gel | Placebo comparator | Device: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProntosanAlso: Double-blind intervetion; Active/placebo comparator unknown.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. | Device | Prontosan Solution and Gel |
| SalineAlso: Double-blind intervetion; Active/placebo comparator unknown.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. | Device | Saline Solution and Inert Gel |
Primary outcome
Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period
Time frame: Baseline and 12 weeks
6 secondary outcomes
Change in absolute wound area dimensions
Time frame: 12-week treatment period
Identification of bacteria present on wound bed at baseline and follow-up
Time frame: 12-week treatment period
Relative change in bacterial load during treatment period
Time frame: 12-week treatment period
Change in wound margins determined by color photography
Time frame: 12-week treatment period
Number of "non-responders" as measured by wound size change (<50% relative wound size reduction
Time frame: 12-week treatment period
Change of clinical wound infection during treatment period
Time frame: 12-week treatment period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Ennis, DO principal investigator
University of Illinois Chicago
Gerit Mulder, DPM principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prontosan and Saline in people with Diabetic Complications, run by B. Braun Medical Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative (%) area wound size change versus baseline in respondents to treatment following a 12-week treatment period (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.