The efficacy of maggots as a debridement agent for venous leg ulcers - Maggot therapy for venous leg ulcers

Gloucestershire Hospitals NHS Foundation Trust0 个研究点目标入组 40 人开始时间: 2008年3月14日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•1) Patient is at least 18 years of age.
•2) Ankle Brachial Pressure Index >/= 0.85 N.B. calculations to be made using Doppler ultrasound measurements from both dorsalis pedis and posterior tibial arteries to minimise error (standard procedure).
•3) Patient has a venous leg ulcer, located between the knee and ankle (at the level of, and including, the lateral and medial malleoli). The ulcer must be confirmed as of venous origin by venous duplex ultrasound.
•4) Patient’s ulcer is a minimum of 4 cm2 and a maximum of 100 cm2 on initial screening.
•5) Patient’s ulcer is covered by a minimum of 20% slough calculated using the manual and computer-aided planimetry method).
•6) Patient understands and is willing to participate in the clinical study and can comply with the follow-up regime.
•7) Patient has read the patient information leaflet and signed the Local Research Ethics Committee approved informed consent form before screening and commencement of trial treatment.
•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

•1) Patient’s ulcer should not show exposed blood vessels, tendon, muscle or bone.
•2) Patients with a history of a bleeding disorder that, in the opinion of the researcher, would make compliance with the trial protocol medically unsafe.
•3) Patients who are unable to understand the aims and objectives of the trial.
•4) Patient has any condition(s), which seriously compromises the patient’s ability to complete this study, or has a known history of poor compliance with medical treatment.
•5) Patient has an aversion to maggots, despite careful and informative discussion between researcher and patient and explanation of the benefits of maggots

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