Larvel Therapy

• Research type

  Research Study

• Full title

  A Randomised Controlled Trial of Larval Therapy in the Debridement of Leg Ulcers

• IRAS ID

  2844

• Sponsor organisation

  BioMonde

• Eudract number

  2007-005775-34

• ISRCTN Number

  n/a

• Research summary

  Leg ulcers are chronic wounds that take weeks or months to heal and are costly to the NHS as well as to patients. It is suggested that larval therapy can remove dead, damaged or infected tissue (debridement) to improve the healing potential of the remaining healthy tissue. BioFOAM is a new type of larval therapy dressing, developed by ZooBiotic (Wales, UK), which requires evaluation as a debriding agent. The BioFOAM dressing contains disinfected larvae of the common greenbottle fly and small pieces of medical-grade foam contained within a mesh pouch. This trial is a randomized, open design; patients with sloughy or necrotic leg ulcers of venous or mixed arterial aetiology will be allocated equally and randomly between the two treatment groups. Treatment of the ulcer to be followed up during the trial which is the largest ulcer on the leg containing at least 25% dead, damaged or infected tissue, will continue for a period of three weeks or until the ulcer is debrided whichever is the sooner.The primary objective of the trial is to compare the clinical effectiveness of BioFOAM with a standard debridement technique Purilon (hydrogel) in terms of the time taken for debridement of leg ulcers. Patients undergoing compression therapy are eligible for inclusion however the compression bandaging will be standardized for the patient during the time they are involved in the trial.The primary outcome is time to debridement of the ulcer. Digital photographs of the ulcer at the start and end of treatment will be used in blinded outcome assessment by two independent reviewers. The trial is sponsored by ZooBiotic Limited, the manufacturer of the BioFOAM dressing. A total of 172 evaluable patients (86 in each treatment group) will be recruited in the UK over 8 study centres. The attrition rate will be monitoried to ensure that 172 evaluable patients are included in the study; allowing for a generous attrition rate of 25%, it is anticipated that no more than 216 patients will be recruited.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/5

• Date of REC Opinion

  16 Jan 2009

• REC opinion

  Favourable Opinion