geko™ Cross Therapy Registry – Wound. Post Market Clinical Follow-up of Safety and Patient Outcomes for Subjects Undergoing Peroneal Nerve Stimulation by geko™
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- 1.Frequency of adverse events
研究概览
简要总结
The gekoâ„¢ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged ≥ 18 years
- •Patients who are diagnosed with a diabetic foot ulcer
- •Intact healthy skin at the site of gekoâ„¢ device application.
- •Willing and able to give written informed consent
- •Identified to receive gekoâ„¢ therapy as part of their standard care for wound management.
排除标准
- •Pregnancy or breast feeding
- •Use of any other neuro-modulation device.
- •Current use of TENS in the pelvic region, back or legs
- •Trauma to the lower limbs that would prevent gekoâ„¢ from stimulating the common peroneal nerve.
- •No response to gekoâ„¢ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting.
结局指标
主要结局
1.Frequency of adverse events
时间窗: Up to 12 months from study entry
Obtain frequency of adverse events (AEs) & serious AEs (SAEs) whether device related or not & compare rate to historic and published data i.e., gekoâ„¢ therapy vs standard care without gekoâ„¢ therapy
时间窗: Up to 12 months from study entry
2.Frequency of device deficiencies
时间窗: Up to 12 months from study entry
Obtain frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e., gekoâ„¢ therapy vs standard care without gekoâ„¢ therapy
时间窗: Up to 12 months from study entry
3. Summary of routinely tested and collected performance data
时间窗: Up to 12 months from study entry
Obtain routinely tested and collected performance data, such as patient reported outcome measures and compare to historic and published data i.e., gekoâ„¢ therapy vs standard care without gekoâ„¢ therapy
时间窗: Up to 12 months from study entry
次要结局
- No secondary outcomes(Up to 84 days from study entry)