A Pilot Open Label Prospective, Randomised, Study to Evaluate the Safety and Efficacy of Keneric Healthcare RTD Wound Dressing in the Treatment of Diabetic Foot Ulcers Compared to Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction in Wound Area
研究概览
简要总结
The goal of this clinical trial is to compare safety and performance of the study device to the current typical NHS standards of care device. The main outcomes it aims to achieve are:
Complete wound healing at 12 weeks (100% epithelialised)
% Reduction in wound area at 12 weeks
Participants will attend their NHS podiatry clinic appointment as normal and will be assigned either the study device or the current typical NHS standard of care device. Researchers will compare the study device group to the standard group to assess the outcomes mentioned previously.
详细描述
The purpose of this clinical trial is to evaluate the safety and performance of the RTD Wound Dressing in the treatment of non-infected neuropathic, ischaemic, and neuro-ischaemic diabetic foot ulcers versus standard of care.
This clinical evaluation study will be performed under an open-label, comparative, design in the single health board of NHS Lanarkshire within 3 diabetic foot clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Subjects will be randomised 1:1 to RTD Wound Dressing or standard of care dressing. Randomisation will be in blocks of four.
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
- •Male or female, aged ≥18 years old with a diagnosis of type 1 or type 2 diabetes.
- •New presentation for treatment of a neuropathic, ischaemic or neuro- ischaemic non- infected DFU
- •Subjects must be able to follow verbal and written instructions in English
- •Subjects must have full mental capacity and able to give written informed consent to participation in the trial including medical photography for the purposes of the clinical trial or clinical care.
- •DFU is >10mm2 and <100mm2
排除标准
- •Known allergy/hypersensitivity to any ingredient contained in the Keneric healthcare RTD Wound Dressing
- •Participants who will have problems following the protocol, including the offloading system, provided as standard of care, to wear on a daily basis
- •Suspected malignancy in the wound
- •Critical limb ischaemia
- •Pregnant or breastfeeding females
- •Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
研究组 & 干预措施
Study Device
This Arm of the study will receive the study device. Although the Study Device is not experimental as it is already CE marked and being used for it's intended purpose.
干预措施: Wound Dressing (Device)
Standard of Care
This arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics.
干预措施: NHS Standard Dressing (Device)
结局指标
主要结局
Reduction in Wound Area
时间窗: 12 weeks
% reduction in size of Wound Area
Completion of Wound Healing
时间窗: 12 weeks
100% epithelialised
次要结局
- Dressing Changes(12 weeks)
- Wound Infection Rates(12 weeks)