Diabetes Mellitus Clinical Trial
— HADIFOfficial title:
HELP-Apheresis in Diabetic Ischemic Foot Treatment (H.A.D.I.F): a RCTrial to Evaluate the Effect of LDL-apheresis on the Recovery of Diabetic Ulcers in Patients With Peripheral Vasculopathy Not Susceptible to Revascularization.
Verified date | January 2017 |
Source | Universita di Verona |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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. Alterations in microcirculatory function and in blood rheology may
concur in causing tissue damage.
In recent years there has been accumulating evidence that LDL apheresis (LA) does not only
reduce cholesterol but also has a series of pleiotropic effects that improve the
microcirculation, increasing peripheral tissue perfusion.
HADIF is a randomized, multicentric, prospective clinical study aimed at assessing the
effect of LDL apheresis treatment in association with traditional therapy for ulcers, in
patients with an ischemic diabetic foot ulcer (class I and II Texas Wound Classification
System)and peripheral vasculopathy not susceptible to revascularization. A total of 132
patients will be enrolled. Participants will be centrally randomized to receive traditional
therapy alone (TT) or in association with LA. TT includes standard medication of ulcers,
antiaggregant therapy and statins. LA will be performed with HELP system, for a total of 10
sessions in 9 weeks. The primary end-point of the study is ulcer healing; secondary
endpoints include improvements of peripheral oxygenation, resolution of pain, reduction of
circulating inflammatory markers, cardiovascular events during one year's follow-up.
This clinical Study has been approved by local EC on 25 may 2011 (Study number 1953).
TO BE NOTED: since diabetic patients in our "Diabetic-Foot UNIT" often presented foot ulcers
more severe than class II Texas, a formal amendment has been submitted to EC for recruiting
patients with diabetic foot ulcer of class III Texas. The amendment was already approved on
5 may 2012.
Status | Completed |
Enrollment | 13 |
Est. completion date | December 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | universita Verona | Verona |
Lead Sponsor | Collaborator |
---|---|
Universita di Verona |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects obtaining the ulcer healing (Class 0A according to TEXAS classification) after 12 month from the study starts. | Ulcer evaluation: staging according to Texas Wound classification System and ulcer evaluation (surface diameter, mapping of the lesions by means of drawing their profiles on Opsite film,and digital picture), at basal, at 9th week and after a 3-6-9-12 month follow-up. | 12 months | No |
Secondary | Improvement of the peripheral oxygenation evaluated by means of transcutaneous oximetry measurement at foot level: TcP O2 (mmHg). | basal, at 4th and 9th week and after 3-6-9-12 month follow-up | No | |
Secondary | Evaluation of pain level variation (verbal numeric range; score from 1 to 10) | basal, at 4th and 9th week and after 3-6-9-12 month follow-up | No | |
Secondary | Lowering of circulating inflammation markers (C Reactive Protein, Fibrinogen). CRP plasmatic concentration (mg/L) and fibrinogen (g/L) | at the beginning of the study and respectively after 3 - 6 - 9 e 12 months. | No | |
Secondary | Rate of cardiovascular events in the observation period (1-year follow-up). | 12 months | No | |
Secondary | proportion of subjects with minor amputation (only toe or part of the foot removed)- in agreement with the approved amendment | 12 months | No | |
Secondary | proportion of subjects with major amputation (these are usually below the knee or above the knee)- in agreement with the approved amendment | 12 months | No |
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