The 3C Patch is a wound therapy developed in 2008 to treat hard-to-heal diabetic foot ulcers. It involves collecting a patient's blood, concentrating cells from it using centrifugation to generate a patch within 20 minutes, and applying the patch directly to the wound. International randomized controlled trials found the 3C Patch almost doubles wound healing rates compared to standard care, with wounds healing in a shorter time and to a greater degree without adverse events.
4. The 3C Patch® Story
4
2011
CE-mark is obtained;
Pilot study results prove efficacy, safety and
potential clinical benefit
CE is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area
6. 6
2017
FDA clearence is obtained for the 3C
Patch® System
The 3C Patch® Story
FDA clearance is a regulatory approval to market the product in the US market
7. 7
2018
International randomized controlled trial:
The results indicate that 3C Patch® almost
doubles the chance of healing compared
to best standard of care
The 3C Patch® Story
8. 8
2019
International Working Group on Diabetic
Foot recommends the use of 3C Patch® for
the treatment of hard-to-heal diabetic foot
ulcers
The 3C Patch® Story
9. 9
2020
3C Patch® is used by clinics in Denmark,
Sweden, Norway, Belgium, Netherlands,
Germany, UK and the US
The 3C Patch® Story
10. 10
3C Patch® Treatment Steps
1. Collection of blood
18 ml of the patient’s blood is
drawn by vacuum into the sterile
device without any additives
2. Centrifugation
3CP® Technology generates a
3C Patch® in a table top
centrifuge within approx. 20
minutes.
3. Application
The device is opened and the 3C
Patch® is applied directly to the surface
of the patient’s wound
11. 11
3C Patch® Structural Overview
In vitro studies show that 3C Patch® has a
high concentration of active cells,
responsible for orchestrating the healing
response
12. 12
89% more likely to heal when accounted for
the wound size distribution between 3C
Patch® and control group
(linear regression model defined in the study protocol CI 1.09-
3.31, p=0.0237, odds-ratio 1.89)
RCT Primary Outcome
1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management
of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology.
Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
13. 13
Time to healing shorter in 3C Patch® group
(72 days) compared to standard of care
group (84 days)
(p=0.0246)
RCT Secondary Outcomes
1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management
of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology.
Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
14. 14
Greater reduction in ulcer area in the 3C
Patch® group (p=0.0168)
RCT Secondary Outcomes
1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management
of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology.
Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
15. 15
No adverse events associated
with the application of 3C Patch®
RCT Secondary Outcomes
1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management
of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology.
Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240