PluroGel on Wounds of Mixed Etiology
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|ClinicalTrials.gov Identifier: NCT03275831|
Recruitment Status : Terminated (Business decision)
First Posted : September 8, 2017
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Venous Ulcer Arterial Ulcer||Device: PluroGel Device: Intrasite gel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Investigate the Efficacy of PluroGel in Healing Venous and Mixed Aetiology Leg Ulcers|
|Actual Study Start Date :||January 8, 2018|
|Actual Primary Completion Date :||October 5, 2021|
|Actual Study Completion Date :||October 5, 2021|
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
Experimental: PluroGel Burn and Wound Dressing
PluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing
Surfactant based gel
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275831
|Aneurin Bevan University Health Board|
|Newport, South Wales, United Kingdom, NP20 4SZ|
|Cardiff & Vale University Health Board|
|Cardiff, Wales, United Kingdom, CF14 4XN|