HELP-Apheresis in Diabetic Ischemic Foot Treatment (H.A.D.I.F) (HADIF)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Foot Ulcers Arteriosclerosis Obliterans Diabetes Mellitus LDL-apheresis |
Device: LDL-apheresis |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | HELP-Apheresis in Diabetic Ischemic Foot Treatment (H.A.D.I.F): a Randomized Controlled Trial to Evaluate the Effect of LDL-apheresis on the Recovery of Diabetic Ulcers in Patients With Peripheral Vasculopathy Not Susceptible to Revascularization. |
- Proportion of subjects obtaining the ulcer healing (Class 0A according to TEXAS classification) after 12 month from the study starts. [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Improvement of the peripheral oxygenation evaluated by means of transcutaneous oximetry measurement at foot level: TcP O2 (mmHg). [ Time Frame: basal, at 4th and 9th week and after 3-6-9-12 month follow-up ] [ Designated as safety issue: No ]
- Evaluation of pain level variation (verbal numeric range; score from 1 to 10) [ Time Frame: basal, at 4th and 9th week and after 3-6-9-12 month follow-up ] [ Designated as safety issue: No ]
- Lowering of circulating inflammation markers (C Reactive Protein, Fibrinogen). CRP plasmatic concentration (mg/L) and fibrinogen (g/L) [ Time Frame: at the beginning of the study and respectively after 3 - 6 - 9 e 12 months. ] [ Designated as safety issue: No ]
- Rate of cardiovascular events in the observation period (1-year follow-up). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- proportion of subjects with minor amputation (only toe or part of the foot removed)- in agreement with the approved amendment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- proportion of subjects with major amputation (these are usually below the knee or above the knee)- in agreement with the approved amendment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 132 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LDL-apheresis in addition to TT
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. |
Device: LDL-apheresis
The patient of the Arm "LDL-apheresis" in addition to standard therapy, will undergo a cycle of LDL-apheresis. LDL-apheresis will be performed with B.Braun Avitum H.E.L.P. System. Apheretic treatment scheme: 10 apheretic sessions carried out as follows: the first 2 with a 3 day distance (i.e. 2 treatments in one week), successively 1 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. Other Names:
|
|
No Intervention: Traditional Treatment
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. |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Maria Grazia Zenti | mariagrazia.zenti@univr.it |
| Italy | |
| universita Verona | Recruiting |
| Verona, Italy, 37100 | |
| Contact: Maria Grazia Zenti, MD +39 0458123745 mariagrazia.zenti@univr.it | |
| Principal Investigator: | Maria Grazia Zenti, MD | Division of Endocrinology and Metabolic Diseases, University Hospital of Verona |
| Study Director: | Enzo Bonora, MD, PhD | Division of Endocrinology and Metabolic Diseases, University Hospital of Verona |
More Information
No publications provided
| Responsible Party: | Maria Grazia Zenti, Maria Grazia Zenti,MD, Division of Endocrinology and Metabolic Diseases, University Hospital of Verona, Universita di Verona |
| ClinicalTrials.gov Identifier: | NCT01518205 History of Changes |
| Other Study ID Numbers: | MZenti HADIF |
| Study First Received: | January 22, 2012 |
| Last Updated: | July 31, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Universita di Verona:
|
diabetic foot ulcers, peripheral arterial disease, heparin-induced extracorporal lipid apheresis. |
inflammatory markers type 2 diabetes LDL-cholesterol |
Additional relevant MeSH terms:
|
Foot Diseases Arteriosclerosis Arteriosclerosis Obliterans Diabetes Mellitus Ulcer Foot Ulcer Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes Skin Diseases Leg Ulcer Skin Ulcer |
ClinicalTrials.gov processed this record on May 23, 2013