Effects of Local Insulin on Wound Angiogenesis and Fibroplasia in Varicose Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Final angiogenesis
研究概览
简要总结
A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7. The number of blood vessels and fibroplasia is evaluated as the main outcome.
详细描述
A randomized, split-plot, double-blind, placebo-controlled trial. Chronic Varicose Ulcers measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria are included in the present study. A split-mouth model is used.
The ulcer is divided into two (sides A and B). The side in which treatment is applied is randomized. Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Both halves are covered with dressings and compression therapy is applied. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7, as control of the local temperature of the wound. This is to asses the process of healing and to correlate with our outcome measures. The number of blood vessels will be evaluated as the main outcome. Fibroplasia and thermal asymmetry between wound sides will be evaluated as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator) Double Blind (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Presence of varicose ulcer in lower extremities with a size greater than 25 cm2
- •Absence of infection
排除标准
- •Presence of diabetes or glycated hemoglobin >6.5%
- •Comorbidities that affect wound healing
- •Malnutrition
- •Active smoking
研究组 & 干预措施
Topical insulin glargine
The wound surface is treated locally with glargine insulin injected sub-dermal in a daily matter for 7 days. Allocation is randomized.
干预措施: Insulin Glargine (Drug)
0.9% saline solution
The wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized.
干预措施: Saline (Drug)
结局指标
主要结局
Final angiogenesis
时间窗: Day 7
Number of blood vessels in a skin biopsy
次要结局
- Fibroplasia(Day 7)
- Thermal asymmetry(Day 7)
- Hypoglycaemia(Day 7)
研究者
MARIO AURELIO MARTÍNEZ-JIMÉNEZ
Professor
Hospital Central "Dr. Ignacio Morones Prieto"