Venous Leg UlcerPhase 4NCT01153633
Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel
A Phase 4 study testing Prontosan Wound Irrigation Solution and Prontosan Wound Gel in people with Venous Leg Ulcer, run by B. Braun Ltd. Centre of Excellence Infection Control at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and inactive gel by showing a reduction in size over a 12 week period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Prontosan Wound Irrigation Solution and Prontosan Wound Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Oct 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and females aged > 18 who are able to give informed consent
- Patients with a chronic venous leg ulcer at any location below the knee joint (CVI grade C6 according to CEAP classification = trophic lesions and open ulcer)
- Venous leg ulcer present for ≥4 weeks
- Surface area of the target ulcer ≥2cm2 and <100cm2 with the largest length not being >10cm
- ABPI ≥ 0.7
Who cannot join
- Age below 18 years
- Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study
- Pregnant or breast feeding women
- Signs and symptoms of clinical infection, or current use of antiseptics or antibiotics
- Involvement in other trials within the past 1 month
- Sensitivity to any of the components of Prontosan® or dressing material
Show all 13Show fewer
- Intolerance to compression therapy
- Active osteomyelitis in the ulceration area
- Active rheumatoid or collagen disease of blood vessels treated with corticosteroids
- Chronic diseases that could impact the course of the study (malicious cancer, TB, AIDS, mental illnesses)
- Plasma protein below 4 g/dl
- Anaemia: haemoglobin below 10 g/dl
- Poorly controlled Diabetes (HBA1C > 12%)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiff University, Department of Wound Healing
Cardiff, Wales, CF14 4XN
About this study
Official title: Pilot, Randomised, Double-blind, Controlled Clinical Trial on the Combined Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel in the Reduction in Size and Change in Bioburden of Hard-to-heal Venous Leg Ulcers
The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and inactive gel by showing a reduction in size over a 12 week period.
Read the detailed description
SUMMARY
Sponsor: B. BRAUN Medical AG
Trade name: Prontosan® Wound Irrigation Solution Prontosan® Wound Gel
Active substance: Polihexanide (0.1%) Betaine (0.1%)
Study Duration (per patient):
13 weeks, including the 1 week run in period
Primary Objective:
To evaluate the efficacy of the combination of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the reduction of wound size of hard-to-heal venous leg ulcers compared to control saline irrigation solution and inactive gel.
Secondary Objectives:
To assess the change in bio-burden (assessment of organisms present) and to determine local tolerance as well as reduction in pain and to monitor exudate control.
Methodology:
A pilot randomised, double-blind, controlled clinical trial at a single centre
Planned number of patients:
A sample size of N= 15 evaluable patients was estimated for each treatment group (group "A" and "B"). Adding a dropout rate of approx. 25% results in a total number of patients for both treatment groups of N=38.
Study Visits:
Visit 0 (-1 week) - Screening Visit 1 ( Week 0) - Treatment and assessment visit Visit 2 (Week 1, day 7 +/- 1 day) - Treatment and assessment visit Visit 3 (Week 2, day14 +/- 1 day) - Treatment and assessment visit Visit 4 (Week 4, day 28 +/- 2 days) - Treatment and assessment visit Visit 5 (Week 8, day 56 +/- 2 days) - Treatment and assessment visit Visit 6 (Week 12, day 84 +/- 2 days) - End of study following 12 weeks of treatment or at healing whichever is soonest
The number of additional visits will be recorded in the Case Report Forms.
Treatment efficacy assessment:
Clinical signs and symptoms will be compared between the two randomised groups with microbiological analysis and, computer planimetry assessments of ulcer size, using Visitrak™ (Smith \& Nephew), and digital photography at entry to the study, at each planned study visit and at healing or 12 weeks, whichever is soonest.
Tolerance assessment:
The tolerability of study treatment will be evaluation based on the intensity and the course of adverse events (undesired concomitant effects, both subjectively perceived symptoms and objectively detected signs of disease). Tolerance assessments will take place from visit 2 onwards
Assessment methods:
- Assessment of clinical signs and symptoms, in particular related to development of infection:
- reduction of slough and necrotic tissue
- control of exudate
- presence of granulation tissue
- reduction of inflammatory signs (surrounding skin)
- pain
- Ulcer computerised planimetry using Visitrak™
- Microbiological analysis for bioburden (the bioburden within an ulcer relates to a microbiological qualitative and quantitative assessment of organisms present) assessed by wound swab or biopsy
- Serial photography with blinded assessment of progress using linear analogue scale
- Conditions
- Venous Leg Ulcer
- Being tested
- Prontosan Wound Irrigation Solution and Prontosan Wound Gel, Normal Saline and Placebo Gel
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prontosan Wound Irrigation Solution and Prontosan Wound GelDevice
The treatment procedures (after a 1 week run-in) include:
- Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation
- Secondary dressing to be a semi occlusive dressing
- Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change.
Normal Saline and Placebo GelDevice
The treatment procedures (after a 1 week run-in) include:
- Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation
- Secondary dressing to be a semi occlusive dressing
- Secure the dressing to the wound with tubifast and short stretch compression system
Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change.
| Study group | Role | What they receive |
|---|---|---|
| Prontosan Wound Solution and Gel | Active comparator | Cleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) Receives: Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel |
| Normal Saline and Placebo Gel | Placebo comparator | Cleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) Receives: Device: Normal Saline and Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change of Wound Size From Baseline to Last Visit
Measured: 12 Weeks
Healing of Target Ulcer atV6/EOS
Number of ulcers healed at V6/EOS
Measured: 12 weeks
Absolute Change of Target Ulcer From Baseline to Last Visit
Measured: 12 weeks
Secondary outcomes (3)
Number of Different Microganisms at V6/EoS
Measured: 12 Weeks
Pain
Absolute change (mm VAS) from baseline to V6/EoS. Pain intensity assessed by patient. At each study visit the patients assessed their pain intensity using a 100 mm Visual Analogue Scale (VAS). Thereby 0 mm represented 'no pain' and 100 mm 'worst possible pain'.
Measured: 12 Weeks
Condition of Wound Bed
Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Leg UlcerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Harding, MD, Principal investigator, Cardiff University, Department of Wound Healing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153633
- Sponsor's protocol ID
- OPM-G-H 0901
- Status last verified
- Mar 2014
- First submitted
- 28 Jun 2010
- Last updated
- 1 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Randomised, Double-blind, Controlled Clinical Trial on the Combined Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel in the Reduction in Size and Change in Bioburden of Hard-to-heal Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01153633
- Acronym / sponsor ID
- OPM-G-H 0901
- Conditions
- Venous Leg Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection ControlIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Posted 1 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and inactive gel by showing a reduction in size over a 12 week period.
Detailed description
SUMMARY
Sponsor: B. BRAUN Medical AG
Trade name: Prontosan® Wound Irrigation Solution Prontosan® Wound Gel
Active substance: Polihexanide (0.1%) Betaine (0.1%)
Study Duration (per patient):
13 weeks, including the 1 week run in period
Primary Objective:
To evaluate the efficacy of the combination of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the reduction of wound size of hard-to-heal venous leg ulcers compared to control saline irrigation solution and inactive gel.
Secondary Objectives:
To assess the change in bio-burden (assessment of organisms present) and to determine local tolerance as well as reduction in pain and to monitor exudate control.
Methodology:
A pilot randomised, double-blind, controlled clinical trial at a single centre
Planned number of patients:
A sample size of N= 15 evaluable patients was estimated for each treatment group (group "A" and "B"). Adding a dropout rate of approx. 25% results in a total number of patients for both treatment groups of N=38.
Study Visits:
Visit 0 (-1 week) - Screening Visit 1 ( Week 0) - Treatment and assessment visit Visit 2 (Week 1, day 7 +/- 1 day) - Treatment and assessment visit Visit 3 (Week 2, day14 +/- 1 day) - Treatment and assessment visit Visit 4 (Week 4, day 28 +/- 2 days) - Treatment and assessment visit Visit 5 (Week 8, day 56 +/- 2 days) - Treatment and assessment visit Visit 6 (Week 12, day 84 +/- 2 days) - End of study following 12 weeks of treatment or at healing whichever is soonest
The number of additional visits will be recorded in the Case Report Forms.
Treatment efficacy assessment:
Clinical signs and symptoms will be compared between the two randomised groups with microbiological analysis and, computer planimetry assessments of ulcer size, using Visitrak™ (Smith \& Nephew), and digital photography at entry to the study, at each planned study visit and at healing or 12 weeks, whichever is soonest.
Tolerance assessment:
The tolerability of study treatment will be evaluation based on the intensity and the course of adverse events (undesired concomitant effects, both subjectively perceived symptoms and objectively detected signs of disease). Tolerance assessments will take place from visit 2 onwards
Assessment methods:
- Assessment of clinical signs and symptoms, in particular related to development of infection:
- reduction of slough and necrotic tissue
- control of exudate
- presence of granulation tissue
- reduction of inflammatory signs (surrounding skin)
- pain
- Ulcer computerised planimetry using Visitrak™
- Microbiological analysis for bioburden (the bioburden within an ulcer relates to a microbiological qualitative and quantitative assessment of organisms present) assessed by wound swab or biopsy
- Serial photography with blinded assessment of progress using linear analogue scale
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 Wound Solution and Gel | Active comparator | Device: Prontosan Wound Irrigation Solution and Prontosan Wound GelCleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) |
| Normal Saline and Placebo Gel | Placebo comparator | Device: Normal Saline and Placebo GelCleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females aged > 18 who are able to give informed consent
- Patients with a chronic venous leg ulcer at any location below the knee joint (CVI grade C6 according to CEAP classification = trophic lesions and open ulcer)
- Venous leg ulcer present for ≥4 weeks
- Surface area of the target ulcer ≥2cm2 and <100cm2 with the largest length not being >10cm
- ABPI ≥ 0.7
Key exclusion criteria (13 listed)
- Age below 18 years
- Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study
- Pregnant or breast feeding women
- Signs and symptoms of clinical infection, or current use of antiseptics or antibiotics
- Involvement in other trials within the past 1 month
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 |
|---|---|---|
| Prontosan Wound Irrigation Solution and Prontosan Wound GelThe treatment procedures (after a 1 week run-in) include: * Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation * Secondary dressing to be a semi occlusive dressing * Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change. | Device | Prontosan Wound Solution and Gel |
| Normal Saline and Placebo GelThe treatment procedures (after a 1 week run-in) include: * Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation * Secondary dressing to be a semi occlusive dressing * Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change. | Device | Normal Saline and Placebo Gel |
Primary outcome
Percent Change of Wound Size From Baseline to Last Visit
Time frame: 12 Weeks
Healing of Target Ulcer atV6/EOS
Time frame: 12 weeks
Number of ulcers healed at V6/EOS
Absolute Change of Target Ulcer From Baseline to Last Visit
Time frame: 12 weeks
3 secondary outcomes
Number of Different Microganisms at V6/EoS
Time frame: 12 Weeks
Pain
Time frame: 12 Weeks
Condition of Wound Bed
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Keith Harding, MD principal investigator
Cardiff University, Department of Wound Healing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prontosan Wound Irrigation Solution and Prontosan Wound Gel in people with Venous Leg Ulcer, run by B. Braun Ltd. Centre of Excellence Infection Control at 1 site in United Kingdom.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change of Wound Size From Baseline to Last Visit (time frame: 12 Weeks). The study lists 3 primary outcomes in all. 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 1 Apr 2014.