Phase 2 trial of repeat dose PDT in chronic venous leg ulcers

• Research type

  Research Study

• Full title

  Phase II randomised, placebo controlled trial to investigate repeat dose antimicrobial photodynamic therapy in patients with chronic venous leg ulcers

• IRAS ID

  9349

• Contact name

  Keith G Harding

• Sponsor organisation

  Photopharmica Ltd

• Eudract number

  2008-005079-90

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Some leg ulcers do not seem to respond very well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing. Because we need to be careful about when we use antibiotics, this study will look at another way of killing bacteria in the wound. This new method involves putting a special. light-activated gel on the ulcer and then shining a particular type of light (visible red light) onto the wound for a short period of time. At the moment we are not sure how many times it is best to use this treatment and so this study will give up to 12 weekly gel & light treatments to each subject and assess any improvement in their ulcers up to this time-point.Across the UK 57 people with chronic leg ulcers will be asked to take part in this study. Up to 10 hospitals will be involved including hospitals in Cardiff, Bradford, Harrogate, Dundee and Airdrie. The research is funded by Photopharmica Ltd.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  08/H0206/68

• Date of REC Opinion

  18 Dec 2008

• REC opinion

  Further Information Favourable Opinion