Butt Muhammad Asghar, Miah Mohammad Mostafizur Rahman, Avabde Dani, Subramaniam Murali
Vascular Surgery, United Lincolnshire Hospital NHS Trust, Lincolnshire, GBR.
Vascular Surgery, Nottingham University Hospital NHS Trust, Nottingham, GBR.
Cureus. 2024 Jun 14;16(6):e62388. doi: 10.7759/cureus.62388. eCollection 2024 Jun.
Background Foot ulcer is a common complication of poorly controlled diabetes and peripheral vascular disease (PVD). The current standard of treatment for diabetic foot ulcers includes the management of underlying risk factors, wound debridement, use of antibiotics for infection, off-loading with cast, and revascularisation surgery. The glyceryl trinitrate (GTN) patch is currently off-licence in treating PVD or diabetic foot ulcers. This study aims to evaluate the effectiveness of the GTN patch in preventing amputation, improving pain control, and reducing the size of tissue loss (ulcer/gangrene) or localised ischaemic area. Method This is a pilot study of 30 patients who were started on the GTN patch from February 2020 to October 2021. Inclusion criteria were patients who have critical limb-threatening ischaemia (CLTI) and with no viable options or are at high risk for revascularisation, both endovascular and open surgery. Patients who were on a GTN patch for less than six weeks at the time of data collection or had unclear outcomes were excluded. The outcomes were retrospectively collected on prevention of amputation, improvement in pain control, and reduction in tissue loss (the size of ulcer/gangrene) or localised ischaemic area with the use of a GTN patch. The binomial test was used to compare the observed outcome of the GTN patch and the expected outcome, which was assumed to be 50% in this study. Results Ninety-three per cent (93%) of the patients who had GTN patches successfully avoided amputation (p<0.0001). Eighty-four per cent (84%) of patients reported better pain control (p=0.0022) and improvement in the size of ulcer/gangrene/localised ischaemic areas (p=0.0005). Conclusion The GTN patch is effective in preventing amputation, improving pain control, and reducing the size of ulcer/gangrene/localised ischaemic areas in patients who have end-stage CLTI and no viable options or who are at high risk for revascularisation surgery.
背景 足部溃疡是糖尿病控制不佳和外周血管疾病（PVD）常见的并发症。糖尿病足溃疡目前的治疗标准包括基础危险因素的管理、伤口清创、使用抗生素控制感染、使用支具减轻负荷以及血管重建手术。硝酸甘油（GTN）贴片目前未获许可用于治疗PVD或糖尿病足溃疡。本研究旨在评估GTN贴片在预防截肢、改善疼痛控制以及减少组织损失（溃疡/坏疽）大小或局部缺血区域方面的有效性。方法 这是一项针对30例患者的试点研究，这些患者于2020年2月至2021年10月开始使用GTN贴片。纳入标准为患有严重肢体威胁性缺血（CLTI）且没有可行治疗方案或血管重建（包括血管内和开放手术）高风险的患者。在数据收集时使用GTN贴片少于六周或结局不明确的患者被排除。回顾性收集使用GTN贴片预防截肢、改善疼痛控制以及减少组织损失（溃疡/坏疽大小）或局部缺血区域方面的结局。采用二项式检验比较GTN贴片的观察结局与预期结局，本研究中预期结局假定为50%。结果 93%使用GTN贴片的患者成功避免了截肢（p<0.0001）。84%的患者报告疼痛控制得到改善（p=0.0022），溃疡/坏疽/局部缺血区域大小有所改善（p=0.0005）。结论 GTN贴片在预防患有终末期CLTI且没有可行治疗方案或血管重建手术高风险患者的截肢、改善疼痛控制以及减少溃疡/坏疽/局部缺血区域大小方面有效。
