DEep VEin Lesion OPtimisation (DEVELOP) Trial: A Randomised, Assessor-blinded Feasibility Study of Iliac Vein Intervention for Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Ulcer Healing - Proportion of ulcers healed
研究概览
简要总结
This is a prospective, single centre, randomised controlled, feasibility study recruiting patients with lower limb venous ulceration and Great Saphenous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (>50%) iliac vein lesions plus compression therapy. The primary endpoints will be ulcer healing and procedural safety. Secondary endpoints include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow up will be over a five-year period. This feasibility study is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the study to definitively address ulcer-healing rates.
详细描述
The single main research question for this trial is as follows: in adult patients with venous ulceration and great saphenous vein incompetence; does iliac vein assessment with IVUS and stenting of significant occlusive disease in addition to superficial great saphenous venous ablation and compression compared to superficial venous ablation and compression alone offer improved ulcer healing rates at three months following treatment?
Primary Objective To determine whether superficial venous ablation plus early iliac vein interrogation plus endovascular stenting in the presence of significant occlusive disease results in improved venous ulcer healing compared to superficial venous ablation plus compression therapy alone.
Secondary Objectives
- To determine the relative performance of duplex ultrasound compared to IVUS for the prediction of NIVLs 3. To determine the rate of primary or recurrent ulceration up to five years following intervention 4. To assess patient quality of life in the short and medium term following each mode of intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consenting patients
- •aged 18 and over
- •ultrasound detected Great Saphenous Venous incompetence
- •an associated primary or recurrent lower limb venous ulcer(s)
排除标准
- •Ankle-brachial pressure index <0.8
- •Previous inability to tolerate lower limb compression bandaging
- •Inability to provide informed consent
- •Previous lower limb arterial revascularisation procedure
- •Contrast allergy
- •Previous history of pelvic malignancy or pelvic radiotherapy
- •Pregnancy
- •Previous iliac vein intervention
- •Previous superficial vein intervention
- •Infection in previous 30 days
- •Estimated glomerular filtration rate (eGFR) < 60 mls/kg/min
- •Isolated short saphenous or perforator vein reflux only
- •Leg ulcer of non-venous aetiology (as assessed by clinician)
- •Unfit for endovascular intervention based on history and examination
- •Any compression therapy within six-months
- •Evidence of deep venous incompetence/thrombosis
研究组 & 干预措施
Control Group
Endovenous ablation of Great Saphenous Vein
干预措施: Endovenous ablation of Great Saphenous Vein (Device)
Intervention Group
Endovenous ablation + iliac US +/- iliac stenting
干预措施: Endovenous ablation + iliac US +/- iliac stenting (Device)
结局指标
主要结局
Ulcer Healing - Proportion of ulcers healed
时间窗: 3-months
Proportion of ulcers healed
Iliac Vein Patency on duplex ultrasound
时间窗: 6-months
Patency of the iliac vein on duplex
Reintervention
时间窗: 12-months
Freedom from re-intervention
次要结局
- Recurrence - Ulcer recurrence(12-months)
- Patient Quality of life using the Aberdeen Varicose Vein Questionnaire(12-months)
- Ulcer healing - Time to ulcer healing(In days)
研究者
Thomas Aherne
Principle Investigator Dr Thomas Aherne
National University of Ireland, Galway, Ireland