Status:
UNKNOWN
Single-centre Study to Investigate Safety and Efficacy of Tri-Solfen in Wound Debridement
Lead Sponsor:
Medical Ethics UK Ltd
Collaborating Sponsors:
ProTherax Ltd
Welsh Wound Innovation Centre Ltd
Conditions:
Wounds Injuries
Anesthesia, Local
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase IIa open, randomised, single and parallel group, therapy controlled, single centre study, which has been divided into 3 sequential phases, which are designed to study respectively, (a)...
Detailed Description
As part of the study, patients with leg ulcers (venous, arterial, mixed aetiology or lymphoedema) requiring surgical debridement will attend 4 visits to the study centre (Day 0, Day 1, Day 7 and Day 1...
Eligibility Criteria
Inclusion
- Male and female patients aged over 18 years of age, with a chronic leg ulcer of arterial, venous, mixed aetiology or lymphoedema willing and able to provide informed consent and comply with study procedures.
- Presence of slough, necrotic or unhealthy tissue that requires removal by surgical (sharp) debridement
- Study wound that is 2-30 cm2 in regards surface area and has been present for 1-60 months.
- Presence of acute, non-cyclic pain experienced by the patient following a previous debridement. A baseline pain score (prior to any administration of treatment) should be \>50mm on a 100mm visual analogue scale
Exclusion
- Patients with an acute or chronic infectious skin disease
- Wound bed with exposed bone, tendon or fascia
- Patients with any anaesthetic allergy or intolerance of local anaesthetics or hypersensitivity to any of the ingredients of the Tri-Solfen or EMLA product
- Patients with cellulitis and/or osteomyelitis
- Patients with porphyria
- Patients with abnormal thyroid function including thyrotoxicosis
- Patients with established ventricular fibrillation, cardiac dilatation (severe angina pectoris, obstructive cardiomyopathy), coronary insufficiency, including angina, organic brain disease or atherosclerosis.
- Patients with clinically significant hepatic or renal insufficiency (glomerular filtration rate \<30mL per minute)
- Patients receiving more than 2 week's treatment with immunosuppressive agents in the past 3 months.
- Patients receiving oral corticosteroid therapy or topical corticosteroid on the leg where the reference ulcer is located.
- Any investigational drug use within 30 days
- Severe malnutrition, as judged by the investigator
- Patients who, in the opinion of the investigator, have an existing condition that would compromise their partcipation and follow up in this study
- Patients who have, or are suspected of having any underlying or skin malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment.
- History of radiation at the study site
- Any other conditions that could impede wound healing
- Patients receiving concomitant medicines including, Carbemazepines, Rifampicin, Phenytoin, Griseofulvin, Phenobarbitone, and Sulphonylureas
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03865147
Start Date
January 15 2019
End Date
July 30 2019
Last Update
March 6 2019
Active Locations (1)
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1
Welsh Wound Innovation Centre
Cardiff, Wales, United Kingdom, CF72 8UX