Passive Training as a Treatment for Diabetic Foot Ulcers: A Randomized, Single-blinded Clinical Trial of Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- The change in Wagner's wound classification.
研究概览
简要总结
Overall project design: This PhD project involves a randomized study on diabetic individuals with healing resistant wounds, comparing the effect of passive movement of the lower limb with standard treatment of diabetic wounds.
How to effectively improve the condition of peripheral arterial disease is limited. The primary purpose of this study is to uncover whether passive movement of the lower limb will influence muscle oxygen demand and thereby increasing blood flow. An increase in muscle oxygen demand is likely to increase both blood flow rate and the number of capillaries, which would induce the healing of wounds, that were not previously possible.
The secondary purpose is to increase understanding of the pathophysiological processes in wound healing through the study of biochemical markers of vascularization, inflammation and stem cell recruitment in blood samples. Further on analyzing the skin and muscle biopsies of the number and quality of endothelial cells and Capillary density and to develop new quantifiable methods to evaluate wound healing in.
The project is a randomized trial, consisting of simple passive training to improve blood vessel function, increase the growth of the smallest blood vessels, thereby preventing ulceration and ultimately amputation.
详细描述
Background information
Diabetic foot ulcers are one of the most frequent and serious complication in diabetes mellitus. Despite attempts of prophylaxis*, only two-thirds of the diabetic foot ulcers eventually heal, and up to 15-20% will ultimately require a minor or major amputation (Major lower extremity amputation is defined as through or above the ankle joint, and minor amputations is below the ankle joint. The incidence of diabetes is growing, but the multifactorial causes of impaired healing of chronic diabetic ulcers are still not well understood.
The diabetic foot ulcers are known to reduce the quality of life for patients both psychically and psychologically and therefore further investigation in new treatment options is plausible. Current knowledge regarding how to improve the condition in the beginning phase of peripheral artery disease (PAD) is limited. Investigators know that high oxygen tension and perfusion of the limb as well as an adequate density of microvessels in the tissue, is essential to wound healing. Therefore, interventions that increase blood flow and promote microcirculatory growth are likely to be beneficial in the treatment of wound healing.
*Dressings, debridement, compression, clinical observation, antibiotics and glycemic control
It has been reported that passive training consisting of knee flexion/extension in a kinetic machine has a beneficial effect on up regulation of growth factors, remicrovascularization and improved blood flow. Høier et al described that passive movement of the leg induced a two-fold elevation in blood flow, elevation of angiogenic factors and initiates capillarization in skeletal muscle. All three factors are often impaired in the diabetic leg, which results in poor wound healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •Diabetes mellitus according to the World Health Organisation (WHO) criteria (see http://www.who.int/diabetes/publications/en/ ) and a stable treatment treated in a period of 14 days prior to screening with insulin or an oral antidiabetic agent. Stable is defined as stable HBA1c.
- •Foot ulcer: size: diameter > 1cm. Duration of wound > 6 weeks Location: Full thickness skin defect distal to the malleoli.
- •Male or female, age >18 years at the time of signing informed consent.
- •Non-dementia diagnosis.
排除标准
- •Major infection; acute cellulitis, osteomyelitis or gangrene anywhere in the affected extremity.
- •Malignant disease
- •Major traumatic tissue damage.
- •Major lower extremity amputation.
结局指标
主要结局
The change in Wagner's wound classification.
时间窗: week 3, 5 and 16
The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8
Wound healing change quantified by digital photo planimetry
时间窗: week 3, 5 and 16
The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8
次要结局
- Perfusion of the lower extremity.(week 0, 3, 5, 8 and 16.)
- Distal blood pressure measurement.(week 0 and 8.)
- Histological changes of the muscle tissue.(Week 0,5 and 8)
- the change in maximum leg extension test(Week 0 and 8)
- Adverse events(Week 0, 3, 5, 8 and 16)
- Histological changes of the tissue composition in the edge of the wound.(Week 0,5 and 8)
- Distal blood pressure change measurement.(week 0 and 8)
- Histological changes of the endothelial cells(0,5 and 8)
- Angiogenetic factors analysed from muscle biopsy(Week 0,5 and 8)
- the change in 30 second chair stand test(Week 0 and 8)
- Histological changes of the capillary density(0,5 and 8)
- Patient related outcome measurements (PROM's)(Week 0, 8 and 16)
- Autonomic neuropathy(Week 0 and 8)
- Dexa Scanning of the lower limb.(Week 0 and 8)
- The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.(Week 0, 5 and 8)
研究者
Tue Smith Jørgensen
Medical Doctor
Herlev Hospital