Extracorporeal Shockwave Therapy for Diabetic Foot Wounds: A Cohort Study Comparing Extracorporeal Shockwave Therapy to Standard Treatment for Diabetic Foot Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Wound Volume
研究概览
简要总结
Diabetic wounds post digital amputation have poor healing in 30-45% of cases, resulting in 75% of patients undergoing a further amputation within the year, despite best wound management.
Extracorporeal shockwave therapy is a promising safe and non invasive treatment that has been shown to improve healing in chronic ulcers and burns by promoting healing and decreasing risk of infection.
The study will recruit patients on a hospital ward and outpatient departments who have a diabetic foot wound. Participants will be informed about the study, given an patient information sheet and invited to give informed consent.
Consenting participants will undergo shockwave therapy three times in the seven days after their operation, in addition to standard wound care.
Wound measurements, blood perfusion, tissue integrity, quality of life and pain scores will be recorded at baseline, after the third treatment, 4 weeks, 8 weeks and 12 weeks after recruitment to the study.
The study aims to recruit 25 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of diabetes mellitus
- •Open wound of the foot
- •ABPI >0.8
- •Age greater than 18 years old
- •Able and willing to give written informed consent
- •Be able to adhere to protocol and attend all follow up appointments
排除标准
- •Pregnancy or breast-feeding
- •Current malignancy
- •Allergy to materials used in the treatment
- •Palliative
- •Unable or unwilling to give consent
- •Anticoagulation
结局指标
主要结局
Wound Volume
时间窗: 12 weeks
Change in wound volume between study visits
次要结局
- Pain Questionnaire(12 weeks)
- Quality of Life Questionnaires SF-12(12 weeks)
- Infection Rate(Recorded at 12 weeks)
- Minor Amputation Rate(Recorded at 12 weeks)
- Local Perfusion Rate(7 days)
- Tissue Integrity(7 days)
- Quality of Life Questionnaire EQ5D3L(12 weeks)