3C Patch for treating diabetic foot ulcers

2.1 3C Patch is a single-use medical device that is used as part of wound care for foot ulcers in people with diabetes. 3C Patch is used in combination with the 3CP centrifuge. Together the device and the centrifuge are referred to as the 3C Patch system.

2.2 The system is used to make an individual, biological patch from a person's own blood. The patch is a disc-shaped layered matrix of fibrin, leukocytes and platelets and acts as a concentrated source of cells, growth factors and signalling molecules, which are thought to promote wound healing.

2.3 To make the patch, blood is drawn directly into the 3C Patch device, and then spun for about 20 minutes in the 3CP centrifuge. The centrifuge has optical sensors and uses an automatic prespecified programme that performs all the steps needed to create the patch. The patch is applied directly to the ulcer and kept in place with a non-adhesive primary dressing. A separate secondary dressing can also be used to manage exudate.

2.4 This evaluation focuses on the use of 3C Patch for the treatment of diabetic foot ulcers (DFUs) that are not healing despite standard care. Current care for DFUs (as outlined in NICE's guideline on diabetic foot problems: prevention and management) includes offloading, debridement, control of ischaemia, and use of dressings. It recommends that clinical assessment and patient preference are taken into account when choosing dressings, but healthcare professionals should choose the lowest cost dressing that is likely to achieve the desired results. This could include use of advanced dressings such as UrgoStart (see NICE's medical technologies guidance on UrgoStart for treating diabetic foot ulcers and leg ulcers). NICE's diabetic foot guideline recommends that other treatments like dermal or skin substitutes should only be considered as an adjunct to standard care when healing has not progressed. The guideline also recommends that other treatments, including autologous platelet-rich plasma gel, should only be used as part of a clinical trial.

2.5 3C Patch is intended to be applied and replaced every 7 days. The company recommends that 3C Patch should be considered when 4 weeks of treatment with standard care has not reduced the ulcer area by at least 50%. The company suggests 3C Patch treatment should be used for 4 to 6 weeks initially, and up to 20 weeks in total, depending on response to treatment as measured by reduction in ulcer area.

2.6 3C Patch is innovative because it uses the person's own blood sample, which is then centrifuged to create a solid patch, with no additional reagents needed from outside the person's body. Immune cells, platelets and growth factors captured in the patch are associated with the processes of tissue repair and the inflammatory response.

2.7 3C Patch is indicated for the management of recalcitrant wounds. The scope of this evaluation is limited to its use for the treatment of DFUs that are not healing despite standard wound care. For this population, the intervention is usually delivered in a multidisciplinary diabetic foot clinic. Healthcare professionals involved in delivering the intervention need to be trained on preparing and applying the patch.

2.8 The 3C Patch kit costs £150 (excluding VAT) and can be used to make 1 patch. Each kit includes the 3C Patch device, needle holder, winged blood sampling set with protector, primary cover dressing (Tricotex), alcohol swab, post-blood-sample adhesive bandage and a ruler with adhesive. The 3CP centrifuge is provided on loan by the company free of charge. Servicing and maintenance of the 3CP centrifuge is also free of charge and the expected lifespan of the centrifuge is at least 7 years. A non-sterile 3CP counterbalance is also needed for balancing the centrifuge.

For more details, see the website for 3C Patch.