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
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Condition or disease | Intervention/treatment | Phase |
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Venous Ulcer Arterial Ulcer | Device: PluroGel Device: Intrasite gel | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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.
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Device: Intrasite gel
Hydrogel |
Experimental: PluroGel Burn and Wound Dressing
PluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing
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Device: PluroGel
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United Kingdom | |
Aneurin Bevan University Health Board | |
Newport, South Wales, United Kingdom, NP20 4SZ | |
Cardiff & Vale University Health Board | |
Cardiff, Wales, United Kingdom, CF14 4XN |
Responsible Party: | Medline Industries |
ClinicalTrials.gov Identifier: | NCT03275831 |
Other Study ID Numbers: |
R17-006 WWIC/2016/02 ( Other Identifier: Welsh Wound Innovation Centre ) |
First Posted: | September 8, 2017 Key Record Dates |
Last Update Posted: | October 20, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Varicose Ulcer Ulcer Pathologic Processes Varicose Veins Vascular Diseases |
Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases |