BBR-012 Diabetic Foot Ulcer Study

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Repeat-Dose, Placebo-Controlled Phase IIa Proof of Concept Study to Investigate the Safety and Efficacy of Oral BBR-012 in Combination With Standard Medical Care in Diabetic Patients With Complicated Skin Ulceration on the Foot (Diabetic Foot Ulcer)

• IRAS ID

  15427

• Sponsor organisation

  Bridge BioResearch Rights (Jersey) Ltd

• Eudract number

  2011-000090-32

• ISRCTN Number

  n/a

• Research summary

  This study is a randomised, double-blind, repeat-dose, placebo-controlled phase IIa study, which will be conducted at approximately 12 across the UK. The study is looking to identify a novel new treatment for wounds such as diabetic foot ulcers.Some patients with diabetes can develop complicated skin ulceration on the foot (Diabetic Foot Ulcer) which can prove challenging to treat. This study is a proof of concept study to look at the safety and efficacy of isoniazid (BBR-012) when combined with the standard medical care received by patients with diabetic foot ulcers. For decades isoniazid has been used as a established anti-tuberculosis treatment, but some research has been conducted which suggests that it may also have an effect on wound healing.This study would aim to recruit 75 subjects, across the 12 NHS hospital sites, with diabetic foot ulcers. These subjects would already be attending these sites for standard care of their skin ulcer. If subjects were recruited they would to be randomised to receive isoniazid or placebo, in addition to their standard medical care. The subjects would be assessed on a weekly basis for 28 days, and then on a fortnightly basis for a further 8 weeks unless there were any safety concerns.Suitable subjects would be male or female with diabetes mellitus, with a single skin ulcer, that's not infected, below the bony prominence on each side of the ankle, but not wholly on the sole of the foot. This ulcer must be at least 1cm by 1cm, and can be either ischaemic or neuro-ischaemic (with or without restricted blood supply). All subjects will be asked to provide written informed consent.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  11/SC/0092

• Date of REC Opinion

  12 May 2011

• REC opinion

  Further Information Favourable Opinion