Status:
TERMINATED
PluroGel on Wounds of Mixed Etiology
Lead Sponsor:
Medline Industries
Conditions:
Venous Ulcer
Arterial Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
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 compar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03275831
Start Date
January 8 2018
End Date
October 5 2021
Last Update
October 20 2021
Active Locations (2)
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1
Aneurin Bevan University Health Board
Newport, South Wales, United Kingdom, NP20 4SZ
2
Cardiff & Vale University Health Board
Cardiff, Wales, United Kingdom, CF14 4XN