HELP-Apheresis in Diabetic Ischemic Foot Treatment (H.A.D.I.F) (HADIF)
Foot Ulcers, Arteriosclerosis Obliterans, Diabetes Mellitus
About this trial
This is an interventional treatment trial for Foot Ulcers focused on measuring diabetic foot ulcers,, peripheral arterial disease,, heparin-induced extracorporal lipid apheresis., inflammatory markers, type 2 diabetes, LDL-cholesterol
Eligibility Criteria
Inclusion Criteria:
- Diabetic patients
- Ischemic diabetic ulcers (class I, II and III Texas Wound Classification System);
- documented peripheral vasculopathy with at least a previous event of failed revascularization (no ulcer healing).
Exclusion Criteria:
- Patient refusal to participate
- BMI > 35 kg/m2
- Ischemic diabetic ulcers class III Texas Wound Classification System
- Patients presenting a bleeding diathesis, malignant tumor, heart failure not allowing extracorporeal technique.
- Haemodialysis
Sites / Locations
- universita Verona
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
LDL-apheresis and TT
Traditional Treatment
The patient of the experimental Arm, in addition to Traditional Therapy (TT), will undergo a cycle of 10 LDL-apheresis session. Apheretic treatment scheme: 10 apheretic session carried out as follow: first and second apheresis with a 3 days interval (i.e. 2 treatment in one week), then one session per week (every 7 days). To perform the treatment, the forearm surface veins will be punctured by means of 17 Ga needles, as an alternative a two-ways CVC will be used.
All patients will receive the traditional treatment for the ulcer healing Standardized medication. All lesions taken into consideration will be treated in a standardized way, with a different approach according to the presence of a possible infection. The evolution of lesions might be documented by means of mapping the same by drawing their profiles on an Opsite film. antibiotics therapy (according to antibiogram). Anti-platelet therapy. Statin therapy.