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PluroGel on Wounds of Mixed Etiology
A Pilot Study to Investigate the Efficacy of PluroGel in Healing Venous and Mixed Aetiology Leg Ulcers
2 other identifiers
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
September 8, 2017
CompletedStudy Start
First participant enrolled
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2021
CompletedOctober 20, 2021
October 1, 2021
3.7 years
August 29, 2017
October 13, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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
4 weeks
Secondary Outcomes (2)
Patient evaluation
Up to 6 weeks
Staff evaluation
Up to 6 weeks
Study Arms (2)
Intrasite Gel
ACTIVE COMPARATORIntrasite 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
EXPERIMENTALPluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known hypersensitivity to any of the wound dressings or compression bandaging to be used in the trial
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aneurin Bevan University Health Board
Newport, South Wales, NP20 4SZ, United Kingdom
Cardiff & Vale University Health Board
Cardiff, Wales, CF14 4XN, United Kingdom
Related Publications (5)
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.
PMID: 3107659BACKGROUNDConnor-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.
PMID: 19411907BACKGROUNDCullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2000;(3):CD000265. doi: 10.1002/14651858.CD000265.
PMID: 10908469BACKGROUNDGottrup 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.
PMID: 20551864BACKGROUNDHunter 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.
PMID: 20421622BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2017
First Posted
September 8, 2017
Study Start
January 8, 2018
Primary Completion
October 5, 2021
Study Completion
October 5, 2021
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share