2025-524738-24-00招募中4 期
Healing Diabetic Foot Ulcers with Semaglutide
Radboud universitair medisch centrum Stichting2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Time (in weeks) to wound closure in patients with a DFU using semaglutide versus standard of care treatment.
研究概览
简要总结
To demonstrate the effect of semaglutide on the time to wound closure in patients with a diabetic foot wound.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes mellitus (T2DM)
- •Presence of an active diabetic foot ulcer
- •Age >18 years
- •Be proficient in either Dutch or English
排除标准
- •Those with current use or who used a GLP-1RA or GLP-1/GIP co-agonist in the previous 6 months.
- •Any contra-indication for semaglutide as outlined in the EPAR (which only consists of allergy to the contents of semaglutide injections)
- •Current pregnancy
- •Previous pancreatitis attributed to use of GLP-1RA
- •End-stage renal disease (defined as estimated-GFR <15 mL/min/m2 or the use of renal replacement therapy)
- •Current use of anti-inflammatory therapy, e.g. prednisolone
- •Life expectancy <3 months
研究组 & 干预措施
Ozempic 1 mg solution for injection in pre-filled pen, Ozempic 0.25 mg solution for injection in pre-filled pen, Ozempic 0.5 mg solution for injection in pre-filled pen, Ozempic 2 mg solution for injection in pre-filled pen
Test
干预措施: Ozempic 1 mg solution for injection in pre-filled pen (Drug)
Ozempic 1 mg solution for injection in pre-filled pen, Ozempic 0.25 mg solution for injection in pre-filled pen, Ozempic 0.5 mg solution for injection in pre-filled pen, Ozempic 2 mg solution for injection in pre-filled pen
Test
干预措施: Ozempic 0.5 mg solution for injection in pre-filled pen (Drug)
Ozempic 1 mg solution for injection in pre-filled pen, Ozempic 0.25 mg solution for injection in pre-filled pen, Ozempic 0.5 mg solution for injection in pre-filled pen, Ozempic 2 mg solution for injection in pre-filled pen
Test
干预措施: Ozempic 0.25 mg solution for injection in pre-filled pen (Drug)
Ozempic 1 mg solution for injection in pre-filled pen, Ozempic 0.25 mg solution for injection in pre-filled pen, Ozempic 0.5 mg solution for injection in pre-filled pen, Ozempic 2 mg solution for injection in pre-filled pen
Test
干预措施: Ozempic 2 mg solution for injection in pre-filled pen (Drug)
结局指标
主要结局
Time (in weeks) to wound closure in patients with a DFU using semaglutide versus standard of care treatment.
Time (in weeks) to wound closure in patients with a DFU using semaglutide versus standard of care treatment.
次要结局
- Rate of >50% reduction in ulcer surface area after 6 week of treatment between study groups (excluding newly formed ulcers)
- Ulcer surface area and depth at every outpatient clinic (relative to baseline)
- The change in ankle-brachial index/toe pressure measurements over time (at inclusion, and after wound closure of 6 months of follow-up)
- Rate of lower limb amputation
- Rate of endovascular intervention in lower extremities
- Rate of infection
研究者
Teba Alnima
Scientific
Radboud universitair medisch centrum Stichting
研究点 (2)
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