Status:
COMPLETED
HELP-Apheresis in Diabetic Ischemic Foot Treatment (H.A.D.I.F)
Lead Sponsor:
Universita di Verona
Conditions:
Foot Ulcers
Arteriosclerosis Obliterans
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Diabetic foot (DF) is a common, severe and costly complication of diabetes. DF is underlied by neuropathy, atherosclerosis of distal arteries and infection, which result in tissue ulcers and necrosis....
Detailed Description
Aim of the protocol is to evaluate the effect of LDL-apheresis in combination with traditional therapy, on the recovery of diabetic ulcers in patients suffering from diabetic ischemic foot and periphe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01518205
Start Date
February 1 2012
End Date
December 1 2015
Last Update
January 4 2017
Active Locations (1)
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1
universita Verona
Verona, Verona, Italy, 37100