DIFU started enrollment
27.04.2022 - DIFU is a multicenter and randomized study conducted in multiple hospitals in Switzerland and Germany. The study aims to demonstrate that immediate revascularization on top of standard wound care leads to reduced cardiovascular and limb events including improved ulcer healing compared to standard wound care alone in patients with non-critical lower extremity arterial disease (LEAD) and Diabetic Foot Ulcer (DFU).
Approximately 80% of diabetes-related lower extremity amputations are preceded by a foot ulcer with LEAD considered to be a leading risk factor. Obtaining pulsatile arterial flow to the ischemic ulcer is the paramount for DFU healing and risk reduction for any amputation. Revascularization is currently recommended in patients with LEAD and non-healing DFU after 6 weeks even though a delay of revascularization leads to the irreversible loss of local tissue with poorer limb salvage rates, especially in diabetics.
The trial is funded by the Swiss National Science Foundation (SNSF, Investigator Initiated Clinical Trial) and is planned to enroll 240 participants over 3 years. The first trial participant was enrolled at the Inselspital Bern in January 2022.
CTU Bern is highly involved in this trial with the following divisions: Clinical Study Management, Statistics & Methodology, Data Management, and Monitoring. Further Information can be found under DIFU website and the kofam study registry.