Venous UlcerNCT03275831
PluroGel on Wounds of Mixed Etiology
A study testing PluroGel and Intrasite gel in people with Venous Ulcer and Arterial Ulcer, run by Medline Industries at 2 sites in United Kingdom.
Trial summary
A randomized controlled study (RCT) to investigate the topical effectiveness of PluroGel in healing venous and mixed aetiology leg ulcers. Patients with venous and mixed aetiology leg ulcers will be identified from hospital outpatient clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer, Arterial Ulcer
- What is being tested?
- PluroGel and Intrasite gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 8 Jan 2018to 5 Oct 2021
- 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
- Patients aged ≥ 18 years old
- Patients with a non-healing venous leg ulcer or mixed aetiology ulcer.
- Duration of wound ≥ 6 weeks ≤ 5 years
- Wound is ≥ 1 cm2 ≤ 100cm2 no length longer than 10cm
- Presence of at least 25% visible slough within the wound bed
- The patient must be able to understand the study and provide written informed consent
- No clinical signs of infection
Who cannot join
- Known hypersensitivity to any of the wound dressings or compression bandaging to be used in the trial
- Current local or systemic antibiotics in the week prior to inclusion
- Clinically infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema.
- Prolonged treatment with immunosuppressive agents or high dose corticosteroids
- Patients who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
- Patients who have participated in a clinical trial on wound healing within the past month
- Patients with a known history of non-adherence with medical treatment
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cardiff & Vale University Health Board
Cardiff, Wales, CF14 4XN
Aneurin Bevan University Health Board
Newport, South Wales, NP20 4SZ
About this study
Official title: A Pilot Study to Investigate the Efficacy of PluroGel in Healing Venous and Mixed Aetiology Leg Ulcers
A randomized controlled study (RCT) to investigate the topical effectiveness of PluroGel in healing venous and mixed aetiology leg ulcers. Patients with venous and mixed aetiology leg ulcers will be identified from hospital outpatient clinics. Willing patients meeting the inclusion and exclusion criteria will be consented and assessed in line with standard care. Participants will be randomized at Week 2 to receive either topical PluroGel or Intrasite gel (an alternative topical hydrogel product) if inclusion criteria is met.
Read the detailed description
This will be a pilot, randomized, controlled, multi-center trial to determine the effectiveness of PluroGel in the reduction of size of wounds and reduction of slough covering the wound surface compared with Intrasite Gel. The primary objectives will be to evaluate the effectiveness of PluroGel compared with Intrasite Gel in the reduction of size of venous leg ulcers or mixed venous arterial aetiology. Also the reduction in the percentage of slough covering the wound bed in both groups will be compared. The secondary objective will be to evaluate patient comfort, satisfaction and acceptance of the hydrogels along with staff feedback of both hydrogels. Patients with either a venous leg ulcer (VLU) or an mixed venous arterial aetiology (MAU) leg ulcer will be identified by the participant's health care provider and will be treated with PluroGel or Intrasite Gel. A total of 40 subjects will be enrolled to the study, 20 to each arm. These subjects will be recruited from patients receiving treatment for wounds at NHS outpatient clinic. Participants will be approached initially by the NHS care-giver and asked if interested in participating in research. If interested, participants will be asked to sign a permission to contact form for contact details to be given to a member of the research team who would then contact the participant to provide further information. A screening log will be kept of all patients who have been considered but who do not fulfill the criteria for entry. Patients will be randomized to either Plurogel and standard care or Intrasite Gel in conjunction with standard care, on an equal basis. Subjects will be eligible for randomization if during the first two weeks within the study the target wound has not reduced in surface area by 30% or more and there has been a less than 25% reduction in the cover of the wound bed with visible slough. Once the subject has completed 4-weeks of treatment, and the final visit, or the target ulcer has healed, whichever is soonest, then the subject has completed the study and the termination form will be completed. The Investigator will ensure that all CRF forms are completed and accurate. The study end date will be the date of the last subject's last visit. The CI and study sponsor, will comply with any safety reporting obligations for serious adverse device related events to the manufacturer, study sponsor, R\&D Department(s) of the University Health Board(s) and the Ethics Committee, as defined in the applicable laws and regulations, and within the required timelines.
- Conditions
- Venous Ulcer, Arterial Ulcer
- Being tested
- PluroGel, Intrasite 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.
PluroGelDevice
Surfactant based gel
Intrasite gelDevice
Hydrogel
| Study group | Role | What they receive |
|---|---|---|
| Intrasite Gel | Active comparator | Intrasite Gel is an effective method for hydrating dry necrotic and sloughy wounds. It is an amorphous gel that contains 85% water, and gently increases the moisture level within the wound, encouraging moist wound healing through autolytic debridement. Receives: Device: Intrasite gel |
| PluroGel Burn and Wound Dressing | Experimental | PluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing Receives: Device: PluroGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound size
Comparison of change in wound surface area (cm2) over a 4 week assessment between baseline and final assessment in PluroGel treated group compared to Intrasite treated group.
Measured: 4 weeks
Change in average percent reduction of slough in wound bed over 4 week treatment
Comparison of change in average percent reduction of slough present in the wound bed observed at baseline and over 4 week treatment period in PluroGel treated group compared to Intrasite treated group
Measured: 4 weeks
Secondary outcomes (2)
Patient evaluation
Survey questions to report adherence to protocol of care, comfort, comparison with previous treatments, level of patient discomfort and pain during use of either PluroGel or Intrasite
Measured: Up to 6 weeks
Staff evaluation
Survey to record staff feedback including ease of application and removal of both PluroGel and the comparator Intrasite.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start8 Jan 2018
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Venous 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275831
- Sponsor's protocol ID
- R17-006
- Other IDs
- WWIC/2016/02
- Status last verified
- Oct 2021
- First submitted
- 29 Aug 2017
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Callam MJ, Harper DR, Dale JJ, Ruckley CV. Arterial disease in chronic leg ulceration: an underestimated hazard? Lothian and Forth Valley leg ulcer study. Br Med J (Clin Res Ed). 1987 Apr 11;294(6577):929-31. doi: 10.1136/bmj.294.6577.929.
PubMed 3107659Connor-Ballard PA. Understanding and managing burn pain: Part 2. Am J Nurs. 2009 May;109(5):54-62; quiz 63. doi: 10.1097/01.NAJ.0000351510.77627.db.
PubMed 19411907Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2000;(3):CD000265. doi: 10.1002/14651858.CD000265.
PubMed 10908469Gottrup F, Apelqvist J, Price P; European Wound Management Association Patient Outcome Group. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. 2010 Jun;19(6):237-68. doi: 10.12968/jowc.2010.19.6.48471.
PubMed 20551864Hunter RL, Luo AZ, Zhang R, Kozar RA, Moore FA. Poloxamer 188 inhibition of ischemia/reperfusion injury: evidence for a novel anti-adhesive mechanism. Ann Clin Lab Sci. 2010 Spring;40(2):115-25.
PubMed 20421622
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Efficacy of PluroGel in Healing Venous and Mixed Aetiology Leg Ulcers
- ClinicalTrials.gov ID
- NCT03275831
- Acronym / sponsor ID
- R17-006
- Conditions
- Venous Ulcer, Arterial Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 8 Sep 2017 (actual)
- 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.
A randomized controlled study (RCT) to investigate the topical effectiveness of PluroGel in healing venous and mixed aetiology leg ulcers. Patients with venous and mixed aetiology leg ulcers will be identified from hospital outpatient clinics. Willing patients meeting the inclusion and exclusion criteria will be consented and assessed in line with standard care. Participants will be randomized at Week 2 to receive either topical PluroGel or Intrasite gel (an alternative topical hydrogel product) if inclusion criteria is met.
Detailed description
This will be a pilot, randomized, controlled, multi-center trial to determine the effectiveness of PluroGel in the reduction of size of wounds and reduction of slough covering the wound surface compared with Intrasite Gel. The primary objectives will be to evaluate the effectiveness of PluroGel compared with Intrasite Gel in the reduction of size of venous leg ulcers or mixed venous arterial aetiology. Also the reduction in the percentage of slough covering the wound bed in both groups will be compared. The secondary objective will be to evaluate patient comfort, satisfaction and acceptance of the hydrogels along with staff feedback of both hydrogels. Patients with either a venous leg ulcer (VLU) or an mixed venous arterial aetiology (MAU) leg ulcer will be identified by the participant's health care provider and will be treated with PluroGel or Intrasite Gel. A total of 40 subjects will be enrolled to the study, 20 to each arm. These subjects will be recruited from patients receiving treatment for wounds at NHS outpatient clinic. Participants will be approached initially by the NHS care-giver and asked if interested in participating in research. If interested, participants will be asked to sign a permission to contact form for contact details to be given to a member of the research team who would then contact the participant to provide further information. A screening log will be kept of all patients who have been considered but who do not fulfill the criteria for entry. Patients will be randomized to either Plurogel and standard care or Intrasite Gel in conjunction with standard care, on an equal basis. Subjects will be eligible for randomization if during the first two weeks within the study the target wound has not reduced in surface area by 30% or more and there has been a less than 25% reduction in the cover of the wound bed with visible slough. Once the subject has completed 4-weeks of treatment, and the final visit, or the target ulcer has healed, whichever is soonest, then the subject has completed the study and the termination form will be completed. The Investigator will ensure that all CRF forms are completed and accurate. The study end date will be the date of the last subject's last visit. The CI and study sponsor, will comply with any safety reporting obligations for serious adverse device related events to the manufacturer, study sponsor, R\&D Department(s) of the University Health Board(s) and the Ethics Committee, as defined in the applicable laws and regulations, and within the required timelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrasite Gel | Active comparator | Device: Intrasite gelIntrasite Gel is an effective method for hydrating dry necrotic and sloughy wounds. It is an amorphous gel that contains 85% water, and gently increases the moisture level within the wound, encouraging moist wound healing through autolytic debridement. |
| PluroGel Burn and Wound Dressing | Experimental | Device: PluroGelPluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥ 18 years old
- Patients with a non-healing venous leg ulcer or mixed aetiology ulcer.
- Duration of wound ≥ 6 weeks ≤ 5 years
- Wound is ≥ 1 cm2 ≤ 100cm2 no length longer than 10cm
- Presence of at least 25% visible slough within the wound bed
Key exclusion criteria (7 listed)
- Known hypersensitivity to any of the wound dressings or compression bandaging to be used in the trial
- Current local or systemic antibiotics in the week prior to inclusion
- Clinically infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema.
- Prolonged treatment with immunosuppressive agents or high dose corticosteroids
- Patients who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
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 |
|---|---|---|
| PluroGelSurfactant based gel | Device | PluroGel Burn and Wound Dressing |
| Intrasite gelHydrogel | Device | Intrasite Gel |
Primary outcome
Change in wound size
Time frame: 4 weeks
Comparison of change in wound surface area (cm2) over a 4 week assessment between baseline and final assessment in PluroGel treated group compared to Intrasite treated group.
Change in average percent reduction of slough in wound bed over 4 week treatment
Time frame: 4 weeks
Comparison of change in average percent reduction of slough present in the wound bed observed at baseline and over 4 week treatment period in PluroGel treated group compared to Intrasite treated group
2 secondary outcomes
Patient evaluation
Time frame: Up to 6 weeks
Staff evaluation
Time frame: Up to 6 weeks
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Background: PubMed 3107659Callam MJ, Harper DR, Dale JJ, Ruckley CV. Arterial disease in chronic leg ulceration: an underestimated hazard? Lothian and Forth Valley leg ulcer study. Br Med J (Clin Res Ed). 1987 Apr 11;294(6577):929-31. doi: 10.1136/bmj.294.6577.929.
- Background: PubMed 19411907Connor-Ballard PA. Understanding and managing burn pain: Part 2. Am J Nurs. 2009 May;109(5):54-62; quiz 63. doi: 10.1097/01.NAJ.0000351510.77627.db.
- Background: PubMed 10908469Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2000;(3):CD000265. doi: 10.1002/14651858.CD000265.
- Background: PubMed 20551864Gottrup F, Apelqvist J, Price P; European Wound Management Association Patient Outcome Group. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. 2010 Jun;19(6):237-68. doi: 10.12968/jowc.2010.19.6.48471.
- Background: PubMed 20421622Hunter RL, Luo AZ, Zhang R, Kozar RA, Moore FA. Poloxamer 188 inhibition of ischemia/reperfusion injury: evidence for a novel anti-adhesive mechanism. Ann Clin Lab Sci. 2010 Spring;40(2):115-25.
- Individual participant dataSharing planned: No
Related trials for Venous Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PluroGel and Intrasite gel in people with Venous Ulcer and Arterial Ulcer, run by Medline Industries at 2 sites 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Oct 2021. 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 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. 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 stopped early (reason given: Business decision). Results are not available in the source record.
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?
Change in wound size (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03275831, which also lists 5 linked publications.
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 20 Oct 2021.