PluroGel on Wounds of Mixed Etiology

Study Overview
=================
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.

Official Title
-----------------
A Pilot Study to Investigate the Efficacy of PluroGel in Healing Venous and Mixed Aetiology Leg Ulcers

Conditions
-----------------
Venous Ulcer, Arterial Ulcer

Intervention / Treatment
-----------------
* Device: PluroGel
* Device: Intrasite gel


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrasite Gel<br>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<br>* Hydrogel<br>|
| Experimental: PluroGel Burn and Wound Dressing<br>PluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing | Device: PluroGel<br>* Surfactant based gel<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Staff evaluation | Survey to record staff feedback including ease of application and removal of both PluroGel and the comparator Intrasite. | Up to 6 weeks |