Fat Grafting in Reducing Recurrence in Patients With Healed Venous Ulcers: A Prospective Randomised Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient's quality of life post fat grafting
研究概览
简要总结
In this study, investigators aim to use fat grafting in patients with previously healed venous ulcers to study its role on increasing skin thickness and reconstructing skin layers which was damaged by venous hypertension and determine its impact on reducing recurrence rates at 1 year
详细描述
Study design:
This is a randomised, prospective, active-control pilot study to compare the effectiveness of fat grafting combined with compression therapy to compression therapy alone on reducing ulcer recurrence in patients with healed venous ulcers in a tertiary vascular care centre. This study will randomise 20 patients with previously healed venous ulcers in an equal ratio to one of two treatment arms. The intervention arm will be randomised to undergo fat grafting combined with compression therapy. The control arm will be offered compression therapy only. They will then be followed up in the outpatient clinic at 4 weeks, 8 weeks and 1 year.
Study setting:
Potential participants will be identified and screened at the vascular outpatient clinics within the Saolta group university hospitals, Ireland. Patients will receive the intervention in operating theatre in Roscommon University Hospital (RUH). Fat grafting will be performed under the supervision of a plastic surgeon. The coordinating centre will be the Department of Vascular and Endovascular Surgery, University College Hospital Galway (UCHG), and the School of Medicine at the National University of Ireland Galway (NUI Galway).
Study screening:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or more.
- •Able to provide written informed consent.
- •Healed primary venous ulcers (C5 on CEAP classification) of 5cm or less for at least 1 month.
- •Ankle-brachial pressure index (ABPI) of 0.8 or more.
排除标准
- •Healed recurrent venous ulcers
- •Evidence of deep venous occlusion
- •Malignancy or immune-suppression
- •Malnutrition
- •Multi-organ failure
- •Pregnancy
研究组 & 干预措施
Fat grafting combined with compression therapy
Fat grafting + compression bandages/stockings
Fat grafting:
For the purposes of this study, the standard technique will be used for all patients
- General or local anaesthesia.
- Performed under the supervision of a plastic surgeon.
- Harvest site will be either abdomen or lower limb.
- After harvesting fat by liposuction, the lipoaspirate (which contains the ASCs) will be injected at the base of the healed venous ulcer within the same aseptic operative setting.
Compression therapy:
compression bandages / stockings as per routine practice
干预措施: Fat grafting (Procedure)
Compression therapy only
Compression therapy:
compression bandages / stockings as per routine practice
结局指标
主要结局
Patient's quality of life post fat grafting
时间窗: 1 year
Chronic Lower Limb Venous Insufficiency Questionnaire - 14 (CIVIQ-14)
次要结局
- Pain severity scores(1 year)
- Skin thickness changes(1 year)
- Recurrence rates(1 year)
- Time to recurrence(1 year)
- Incidence of adverse events(1 year)
研究者
Mohamed Elsharkawi
Mr
National University of Ireland, Galway, Ireland