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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Proportion of subjects obtaining the ulcer healing (Class 0A according to TEXAS classification) after 12 month from the study starts.
研究概览
简要总结
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.
详细描述
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 peripheral vasculopathy that cannot be revascularized.
Patients who qualify for the study will be randomized to the traditional treatment combined to apheresis (Experimental Arm) or to the standard treatment only (control Arm).
The randomization stratified according to the lesion gravity level (class TEXAS I vs II vs III),allocation 1:1. The randomization list will be generated by the statistic software "Stata 11". The lists of randomization (one list for each class TEXAS ) will be generated and will be stored by the coordinator centre. When a patient satisfies the study inclusion criteria, will be contacted the coordinator centre (by phone/mail) for group allocation.
132 patients will be enrolled (66 patients in experimental arm, 66 patients in control arm).
Traditional Therapy (TT) includes standard medication of ulcers, antiaggregant therapy and statins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Proportion of subjects obtaining the ulcer healing (Class 0A according to TEXAS classification) after 12 month from the study starts.
时间窗: 12 months
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.
次要结局
- 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)
- 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.)
- Rate of cardiovascular events in the observation period (1-year follow-up).(12 months)
- proportion of subjects with minor amputation (only toe or part of the foot removed)- in agreement with the approved amendment(12 months)
- proportion of subjects with major amputation (these are usually below the knee or above the knee)- in agreement with the approved amendment(12 months)
- 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)
研究者
Maria Grazia Zenti
Maria Grazia Zenti,MD, Division of Endocrinology and Metabolic Diseases, University Hospital of Verona
Universita di Verona