2.1. Patient Cohort
amputation, venous by-pass, venous by-pass function, necrosis
NECROSIS, INFILTRATION, ULCERATION
The group consisted of 18 patients (12 males and 6 females) with a mean age of 68 years (range 57–78), all suffering from DFS, and all patients had the following medical history: A small ulceration, necrosis of the finger(s) or a non-healing wound after finger amputation.All were categorized as grade IV on the Fontaine scale.They had received previous intensive treatment with no improvement for at least 14 days.They had a confirmed ischemic DFS variant with TcPo2 (transcutaneous oxygen pressure) ≤ 40 mmHg or ABI (ankle-brachial index) ≤ 0.4. Glycated hemoglobin (Hba1c) was determined in all patients at the start of treatment.At 2–5 days after revascularization surgery, venous by-pass function was assessed using ultrasonography, and ABI and TcPo2 at ankle level were performed.In 15 patients, the function of the graft was assessed well. In the remaining 3, despite the repair procedures, the venous by-pass became obstructed, and in 2 patients, a large amputation was required in the subsequent course, while in 1 (gene therapy group), a stationary ulceration persisted.Patients were randomly assigned to a group in which a bicistronic plasmid containing growth factor genes, hepatocyte growth factor/ vascular endothelial growth factor (HGF/VEGF), was administrated or to a control group (saline administered intramuscularly). This was a double-blind trial in which only one of the study authors knew the formulation (he prepared it).Observations were made after 7, 30, 90, and 180 days. Subsequently, the following were documented:The status of the ischemic lesion (extent, demarcation, presence of necrosis, and infiltration of adjacent tissues/ulceration (extent, depth, activity-granulation, or anergy)). All lesions were documented with photographs and descriptions.ABI—the ratio of the highest pressure from the anterior or posterior tibial artery to the highest systolic pressure in the arm.TcPO2—the Medicap Precise 8001 device was used for these measurements.CDU (color duplex ultrasonography).