| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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 |
|
| E.2.2 | Secondary objectives of the trial |
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. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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.
|
|
| E.4 | Principal 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.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Complete ulcer closure/epithialisation |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Yes |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial will be the last visit of the last subject recruited in the trial as per the protocol.
Subjects will receive good standard care after the end of the trial as outlined in the study protocol. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 3 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | |
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