Global study to help improve quality of life for patients with diabetes

Researchers at the Manchester Royal Infirmary’s Diabetes Centre and Vascular Surgery Department together with microbiologists from The University of Manchester have recruited the first patient into a global study evaluating the best surgical practice to remove dead tissue from wounds that fail to heal effectively.

The results of the study may lead to changes in clinical care that significantly improve quality of life for patients with diabetes.

Around 2.9 million people in the UK are known to suffer from diabetes, and the condition can lead to a marked loss of feeling in the feet which, coupled with poor circulation, makes the development of foot ulcers relatively common. Ulcers can quite easily become infected and typically take a very long time to heal. In severe cases, the infection can spread to the surrounding bone and joints and become gangrenous, at which point it is necessary to amputate the limb.

To help prevent this circumstance from occurring, patients with diabetes who have infected foot ulcers must be treated quickly and effectively. Traditionally, this would be achieved by surgically removing dead or infected tissue using a scalpel blade, while leaving healthy tissue intact, thus reducing the spread of the infection.

However, this procedure can now be performed using a novel technology known as the WoundWand™ Debridement Device, which preclinical trials suggest may be more effective at reducing bacterial counts. It is hoped this could improve the pace of recovery, thereby helping patients with diabetes to recuperate more quickly. The new research study will evaluate the effectiveness of using a WoundWand compared with a scalpel blade to assess the difference in bacterial count, reduction in wound size and improved recovery time.

Chief investigators Drs Frank Bowling and Tawqeer Rashid believe the results of this study could considerably improve the quality of life of patients undergoing these types of procedures, particularly as the improper removal of dead tissue from infected wounds is a primary cause of recurring infection, which significantly increases the risk of amputation.

“We are very proud that our team has recruited the first global patient into this important clinical study. By ensuring that patients get the most effective treatment for ulcers, we can improve recovery time,” Drs. Bowling & Rashid, based at the Manchester Diabetes Centre and Department of Vascular Surgery respectively, part of Central Manchester University Hospitals NHS Foundation Trust, said.

The WoundWand uses radiofrequency energy to gently and precisely dissolve soft tissue, thereby minimising damage to healthy tissue. The device is a type of Coblation technology, which is already used for wound care, for instance in Sports Medicine, but this will be the first time such techniques have been used to treat diabetic foot ulcers.

Patients taking part in the research, sponsored by creator of the WoundWand ArthroCare, will be treated using either a scalpel or the WoundWand device and will be followed up over 12 weeks to assess the healing of their wound.

The delivery of the study is supported by the National Institute for Health Research (NIHR) Clinical Research Network.

Working closely with Drs. Angela Oates and Andrew McBain from The University of Manchester’s Pharmacy School, who will analyse samples taken during the study, the Manchester Diabetes Centre will be one of three across Europe to run the study over the course of one to two years. Overall, 60 patients will be recruited, most of whom will be suffering from diabetic foot ulcers. The study will also test the effectiveness of WoundWand at treating chronic, acute and venous ulcers in non-diabetic patients.

ENDS

Notes for editors

For further information please contact:

Emma Smith
0161 701 2679 / 0782 514 2219
Emma.smith@cmft.nhs.uk

Lucy Prosser
0161 701 0260 / 0782 514 2219
Lucy.prosser@cmft.nhs.uk

For information on the University of Manchester involvement, please contact: Alison Barbuti Media Relations Officer for Faculty of Medical and Human Sciences – part of Manchester Academic Health Science Centre (MAHSC) and Manchester Cancer Research Centre (MCRC)

Central Manchester University Hospitals NHS Foundation Trust is a leading provider of specialist healthcare services in Manchester, treating more than a million patients every year. Its eight specialist hospitals (Manchester Royal Infirmary, Saint Mary’s Hospital, Royal Manchester Children’s Hospital, Manchester Royal Eye Hospital, University Dental Hospital of Manchester and Trafford Hospitals) are home to hundreds of world class clinicians and academic staff committed to finding patients the best care and treatments. (www.cmft.nhs.uk)

The University of Manchester The University of Manchester, a member of the Russell Group, is one of the largest and most popular universities in the UK. It has 20 academic schools and hundreds of specialist research groups undertaking pioneering multi-disciplinary teaching and research of worldwide significance. According to the results of the 2008 Research Assessment Exercise, The University of Manchester is one of the country’s major research institutions, rated third in the UK in terms of ‘research power’. The University has an annual income of £807 million and is ranked 40th in the world and fifth in the UK for the quality of its teaching and impact of its research.

ARTHROCARE ArthroCare develops and manufactures surgical devices, instruments, and implants that strive to enhance surgical techniques as well as improve patient outcomes. Its devices improve many existing surgical procedures and enable new minimally invasive procedures. Many of ArthroCare's devices use its internationally patented Coblation® technology. This technology precisely dissolves target tissue and limits damage to surrounding healthy tissue. ArthroCare also develops surgical devices utilizing other patented technology including its OPUS® line of fixation products as well as re-usable surgical instruments. ArthroCare is leveraging these technologies in order to offer a comprehensive line of surgical devices to capitalize on a multi-billion dollar market opportunity across several surgical specialties, including its two core product areas consisting of Sports Medicine and Ear, Nose, and Throat as well as other areas such as spine, wound care, urology and gynecology

The Clinical Research Network is part of the National Institute for Health Research. 

We provide researchers with the practical support they need to make clinical studies happen in the NHS, so that more research takes place across England, and more patients can take part. 

This practical support includes:

• Reducing the “red-tape” around setting up a study
• Enhancing NHS resources, by funding the people and facilities needed to carry out research “on the ground”
• Helping researchers to identify suitable NHS sites, and recruit patients to take part in research studies
• Advising researchers on how to make their study “work” in the NHS environment

Please see www.crn.nihr.ac.uk for further information