Local Inoculation of Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Healing time
研究概览
简要总结
This is a randomized controlled monocentric study on 114 diabetic patients with the aim of evaluating the efficacy of the lipofilling with Lipogems® system in diabetic patients that are candidates for a minor amputation in the foot. In particular, it will be evaluated whether the lipofilling will be able to shorten the healing times and to reduce the number of major amputations, with consequent positive impact on the quality of life. Patients will be randomized to the treatment group with Lipogems® (local injection of autologous micro-fractured adipose tissue) or to the control group, thus, treatment according to standard clinical practice.
详细描述
Primary objective of this study is the evaluation of the time of the healing of the lesions resulting from minor amputations (digital or forefoot) treated with Lipogems® technique.
Secondary objectives are: 1) assessment of the safety of the lipofilling; 2) evaluation of the intensity of pain (VAS); 3) assessment of the skin tropism; 4) calculation of the relapse rate (defined as the occurrence of local infections, dehiscence and suffering of skin flaps that lead to a revision of the amputation stump or amputation at a higher level); 5) evaluation of the time of hospitalization and quality of life (QoL).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetes (diabetes mellitus type 1 and type 2) of both sexes over the age of 18 years.
- •Presence of irreversible gangrene digital or localized at forefoot (with X-ray of the foot negative or positive for osteolytic lesions at phalanges and/or metatarsus).
- •Patients with vascular problems absent or resolved (evaluated with Eco Color Doppler and ABI (Ankle Brachial Index, that calculates the ratio of the systolic pressure measured at the ankle and the systolic pressure in the arm, both measured in supine position using wave continue Doppler. If assessable, it has to be greater than/equal to 0.7) and pressure index finger/arm TBI (Toe Brachial Index, if assessable, it has to be greater than/equal to 0.6) and/or by the determination of the transcutaneous oxygen pressure (TcPO2 that needs to be equal to or greater than 30mmHg).
排除标准
- •Oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
- •Patient under steroid therapy
- •Active vascular issues
研究组 & 干预措施
Control
Routine clinical practice
Intervention
Lipogems - local injection of autologous micro-fragmented adipose tissue
干预措施: Lipogems (Device)
结局指标
主要结局
Healing time
时间窗: 6 months
Healing time after the minor amputation intended as the complete healing of the amputation stump
次要结局
- Total time of immobility(6 months)
- Total time of hospitalization(6 months)
- Quality of Life using the Short Form 36 (SF-36) questionnaire(6 months)
- Safety: All types of adverse events will be collected(6 months)
- Incidence of relapse(6 months)
- Pain assessed using the Visual Analogue Scale (VAS) for pain(6 months)
研究者
Giulia Trevisi Borsari
Dr
University of Modena and Reggio Emilia