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Trial record 1 of 3 for:    plurogel
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PluroGel on Wounds of Mixed Etiology

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ClinicalTrials.gov Identifier: NCT03275831
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Medline Industries

Tracking Information
First Submitted Date  ICMJE August 29, 2017
First Posted Date  ICMJE September 8, 2017
Last Update Posted Date February 21, 2020
Actual Study Start Date  ICMJE January 8, 2018
Estimated Primary Completion Date July 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PluroGel on Wounds of Mixed Etiology
Official Title  ICMJE A Pilot Study to Investigate the Efficacy of PluroGel in Healing Venous and Mixed Aetiology Leg Ulcers
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Venous Ulcer
  • Arterial Ulcer
Intervention  ICMJE
  • Device: PluroGel
    Surfactant based gel
  • Device: Intrasite gel
    Hydrogel
Study Arms  ICMJE
  • 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.
    Intervention: Device: Intrasite gel
  • Experimental: PluroGel Burn and Wound Dressing
    PluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing
    Intervention: Device: PluroGel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 22, 2021
Estimated Primary Completion Date July 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Keith G Harding, CBE 44 (0) 1443 231457 keith.harding@wwic.wales
Contact: Kara Cassady, BS 847-643-3809 kcassady@medline.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03275831
Other Study ID Numbers  ICMJE R17-006
WWIC/2016/02 ( Other Identifier: Welsh Wound Innovation Centre )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medline Industries
Study Sponsor  ICMJE Medline Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medline Industries
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP