Sponge & levofloxacin v's levofloxacin in moderate infected leg ulcers
Research type
Research Study
Full title
A Randomised, Controlled, Open-Label Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge (Collatamp G) in Combination with Antimicrobial Therapy Compared to Antimicrobial Therapy Alone in Diabetic Patients with with Moderately Infected Lower Extremity Skin Ulcers.
IRAS ID
5935
Contact name
Michael Edmonds
Sponsor organisation
Innocoll Technologies Ltd.
Eudract number
2008-001376-73
ISRCTN Number
not applicable
Clinicaltrials.gov Identifier
Research summary
Infected skin ulcers are common in diabetic patients. They often become severely infected and as a result more difficult to heal successfully. Underlying abnormalities from diabetes can increases the risk of repeated ulcers and infection. In some cases amputation may be the only option if the wound cannot be healed successfully. Treating moderately infected skin ulcers with both oral and topical antibiotics placed directly onto the wound increases the concentration of antibiotic at both the wound site and in the body and could be beneficial to quicker and successful healing. The study is designed to test the safety and effectiveness of a gentamicin-collagen sponge combined with antibiotics versus treatment with antibiotics alone. Participants are randomly assigned to either treatment with a sponge (the sponge size dependent on the wound size) and an antibiotic or an antibiotic alone at the start of the study. Both doctor and participant will know which treatment they are assigned to (open-label). Treatment will be for up to 28 days with the sponge being changed and/or the antibiotic being taken daily. Participants could attend for up to 7 visits in the 28 days, however if at a visit the doctor decides the wound is completely healed that visit will become the end of treatment visit. No further treatment will be required and participants asked to return for evaluation in two weeks time. This last visit will be the point of completion of the study. All participants will be trained on how to apply the sponge to their ulcer and/or when to take their antibiotics and on standard daily care and re-dressing the wound. The sponsor and funder of this study is Innocoll Technologies Ltd. King's College Hospital, London will be recruiting participants for the study.
REC name
London - South East Research Ethics Committee
REC reference
08/H1102/94
Date of REC Opinion
19 Nov 2008
REC opinion
Further Information Favourable Opinion