A double blind prospective randomised controlled trial to evaluate the effect of topical phenytoin on the healing of venous leg ulcers - Phenytoin in the treatment of chronic wounds 8.10

lster Community & Hospitals Trust0 个研究点目标入组 146 人2005年8月18日

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注册库

who.int

开始日期

2005年8月18日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

lster Community & Hospitals Trust

•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

•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 Participants who develop cellulitis during the trial should not be withdrawn if compression bandaging is tolerated.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•Patients who have participated in the trial previously and who have recurred or withdrawn.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.