PluroGel on Wounds of Mixed Etiology

October 13, 2021 updated by: Medline Industries

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Wales
      • Newport, South Wales, United Kingdom, NP20 4SZ
        • Aneurin Bevan University Health Board
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • Cardiff & Vale University Health Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intrasite Gel
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.
Device: Intrasite gel
Hydrogel
Experimental: PluroGel Burn and Wound Dressing
PluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing
Device: PluroGel
Surfactant based gel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient evaluation
Time Frame: Up to 6 weeks
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
Up to 6 weeks
Staff evaluation
Time Frame: Up to 6 weeks
Survey to record staff feedback including ease of application and removal of both PluroGel and the comparator Intrasite.
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medline Industries

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R17-006
  • WWIC/2016/02 (Other Identifier: Welsh Wound Innovation Centre)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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