Venous Leg Ulceration
Conditions
Interventions
Product Name: PR1
Pharmaceutical Form: Impregnated dressing
INN or Proposed INN: Phenytoin sodium
CAS Number: 630-93-3
Current Sponsor code: PR1
Other descriptive name: Phenytoin base USB
Concentratio
Sponsors
Ulster Community & Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: at least 18 years of age. Gender: Males Females provided they are not pregnant Presentation: a venous ulcer below the level of the knee, present for at least 2 weeks. Patients with ulcers only on the foot will be excluded. Diagnosis: Patients with an ABPI of 0.7 or above, but not exceeding 1.2 will be considered to have moderate peripheral vascular disease and will be included in the study. The presence of chronic venous hypertension will be on clinical examination and confirmed by Photoplethysmograhy (PPG). Patients who have had significant peripheral vascular disease and have had successful revascularisation with an ABPI of 0.7 or above. The ulcer size will be between more than 1 cm2 and not exceeding 100cms2. Patients who have controlled infection with a positive wound swab but who are managed and responding to systemic antibiotics. The patient is able to understand the trial and is willing to give written consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with significant arterial disease with an ABPI of <0.7. Patients with other causes of ulceration apart from venous and combined moderate arterial disease. Patients on oral phenytoin as part of another treatment regime. Patients with significant hepatic and renal impairment. Females who are pregnant or planning to become pregnant. Patients with clinically defined active cellulitis at first presentation. These patients may be reconsidered for the trial once the infection shows signs of responding to systemic antibiotics. Participants who develop cellulitis during the trial should not be withdrawn if compression bandaging is tolerated. However, such cases should be noted as adverse incidents. Patients who have participated in the trial previously and who have recurred or withdrawn. Patients who are unable to understand the aims and objectives of the trial. Patients with a known history of non-concordance with medical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are: % ulcers closed at 4, 8, and 12 weeks % change in ulcer size at 4, 8 and 12 weeks To determine whether venous leg ulcers treated with phenytoin are more or less likely to recur at 12 and 24 weeks.;Main Objective: The study hypothesis is that the application of topical phenytoin every 3-4 days will increase the rate of healing in venous leg ulcers. The main study objective is to determine the clinical outcomes, positive or negative in patients with venous leg ulceration treated with phenytoin v placebo including: % ulcers closed at 16 weeks % change in ulcer size at 16 weeks;Primary end point(s): Complete ulcer closure/epithialisation | — |
Countries
United Kingdom
Outcome results
None listed