Manchester Royal Infirmary leads diabetic wound care research

Manchester University NHS Foundation Trust is leading recruitment on a clinical trial evaluating the feasibility of a medical device in the treatment of Diabetic Foot Ulcers (DFU).

The study is assessing the use of the ReGenerCell in the safe and effective treatment of this widespread complication of diabetes.  The device has been created by Avita Medical Ltd, a regenerative medicine company specialising in the treatment of wounds and skin defects. It has already been investigated in the treatment of Venous Leg Ulcers (VLUs).

Manchester Royal Infirmary (MRI) received the green light to start recruitment to the DFU study in January 2016. It is one of three recruiting sites, along with Northwick Park Hospital and King’s College Hospital in London. So far MRI has recruited 16 patients, with eight patients progressing to having treatment with the device.

Nationally, the study aims to enroll up to 24 patients with DFUs, who will each be followed over a 26-week evaluation period. Recruitment is due to finish before December 2018. 

The ReGenerCell device enables medical professionals to create an autologous suspension of the patient’s own skin cells, which are then applied to the patient’s wound to trigger healing. Participants receive ReGenerCell treatment in addition to standard care, including debridement, cleansing, dressings and offloading.

The study is looking at clinical outcomes such as the incidence of healing and rate of healing, as well as patient and physician satisfaction. It is on the NIHR Clinical Research Network portfolio and delivered at MRI with the support of CRN Greater Manchester.

The procedure is performed in theatre and takes around 45 minutes from collecting the skin sample to treatment of the affected area. In cases of chronic wounds, including DFUs and VLUs, the suspension is sprayed or dripped onto the skin.

Bradley Tallon, Senior Clinical Trials Coordinator for Surgery at Manchester Royal Infirmary, said:

The quality of life among patients living with DFUs is often severely reduced and we were proud to have MRI as the first site to treat a patient with the ReGenerCell in 2016.

“We have had some really promising results so far and it seems that the device may well promote wound healing in this particular cohort of patients. We look forward to learning exactly what the study has found once it has been completed.”