Venous Ulcer Clinical Trial
Official title:
A Pilot Study to Investigate the Efficacy of PluroGel in Healing Venous and Mixed Aetiology Leg Ulcers
Verified date | October 2021 |
Source | Medline Industries |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 16 |
Est. completion date | October 5, 2021 |
Est. primary completion date | October 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cardiff & Vale University Health Board | Cardiff | Wales |
United Kingdom | Aneurin Bevan University Health Board | Newport | South Wales |
Lead Sponsor | Collaborator |
---|---|
Medline Industries |
United Kingdom,
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. — View Citation
Connor-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. Review. — View Citation
Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2000;(3):CD000265. Review. Update in: Cochrane Database Syst Rev. 2001;(2):CD000265. — View Citation
Gottrup 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. — View Citation
Hunter 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | Up to 6 weeks | |
Secondary | Staff evaluation | Survey to record staff feedback including ease of application and removal of both PluroGel and the comparator Intrasite. | Up to 6 weeks |
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