A novel therapy using human PTH 1-84 in the acute Charcot foot

• Research type

  Research Study

• Full title

  A novel therapy using recombinant human PTH 1-84 to stimulate bone repair and enhance fracture healing in the acute Charcot foot: a double blind placebo controlled study phase IV

• IRAS ID

  26274

• Contact name

  Michael Edmonds

• Sponsor organisation

  Guy’s and St Thomas’ NHS Foundation Trust

• Eudract number

  2009-016873-13

• ISRCTN Number

  N/A

• Research summary

  Some people with diabetes and nerve damage can develop a bone and joint disease known as the ??Charcot foot? in which there is considerable bone destruction. Charcot is the name of the French doctor who first described this condition. Charcot foot can lead to deformity, foot ulcers and long hospital admissions. The quality of life of these patients is reduced as they present with many fractures in the foot which are difficult to heal. At present, patients are given casting treatment which can take on average 10 months. However, fractures in some patients take longer to heal and casting treatment may be as long as 20 months. The purpose of the study is to find out whether a special treatment called recombinant human parathyroid hormone 1-84 (rh PTH) can improve the bone repair and healing of bone fracture in the Charcot foot. We wish to assess how effective is this treatment by treating two groups of patients - one group of patients will receive the treatment itself, and the other group will receive ??placebo? or ??dummy? treatment. Patients will be allocated to one of each group by chance. If this agent speeds up healing of fractures in the Charcot foot, this should cause the foot to resolve quickly with less deformity. In the long run, ulcers should be prevented, the number of hospital admissions and amputations reduced and quality of life improved.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/113

• Date of REC Opinion

  16 Dec 2009

• REC opinion

  Favourable Opinion