Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer: A Prospective Double-Blind, Randomized Control Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in wound size
研究概览
简要总结
Diabetic foot ulcers are associated with high risk of amputation. About 50% of patients undergoing non-traumatic lower limb amputations are diabetics5. The 5-year amputation rate is estimated to be 19% with a mean time to amputation 58 months since the onset of an diabetic foot ulcer6.Because infection and tissue hypoxia are the major contributing factors for non-healing diabetic foot ulcers, hyperbaric oxygen therapy (HBO) carries a potential benefit for treating these problematic wounds that do not respond to standard therapy.
The role of oxygen in the wound healing cascade and subsequent combatting action against bacterial invasion, especially anaerobes, is well documented.14 Delayed or arrested healing and the development of infection is a direct result from decreased perfusion and poor oxygenation of tissue.15 The presence of wound hypoxia is an major etiological pathway in the development of chronic non-healing diabetic foot ulcers
详细描述
1 KHUH Research Center
The Premise of the study:
Hyperbaric Oxygen as adjunctive therapy is effective towards the healing of diabetic lower extremity ulcers and has a role to play in major amputation prevention for persons with Diabetes Mellitus.
Title of the project:
Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extremity Diabetic Ulcers: A Prospective, Double-Blind, Randomized, Controlled Clinical Trial Background Diabetes Mellitus is a major health problem with significant morbidity and mortality. The number of people with diabetes mellitus worldwide is estimated at 285 million in 2010; and expected to increase to 438 million by 20301. In western countries, like the United Kingdom, diabetic foot ulcers are the most commonly found chronic wound2. A diabetic foot ulcer is defined as a 'full thickness' lesion of the skin, that is, a wound penetrating through the dermis below the ankle joint3. The lifetime risk of developing foot ulcers in diabetics is estimated to be 15%4. These ulcers may heal with proper wound care, but some may become chronic and others may lead to amputation. These different outcomes are influenced by several risk factors including, among others, peripheral arterial disease (ischemia), peripheral neuropathy, mechanical foot deformity, poor foot care and inappropriate shoe wear.
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, Care Provider)
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
- •Any gender aged > 18 years.
- •Confirmed type 1 or type 2 Diabetes Mellitus patient, currently on anti-diabetic medication
- •Participant is to have at least one wound, which meets ALL of the following criteria: a. The ulcer to be present on the lower extremity below the ankle joint to make this study comparable to others done on diabetic patients b. Documented proof of chronicity (present for more than 3 months, despite conventional wound care).
- •c. Wagner classification Grade 3 or higher as recommended by the Undersea and Hyperbaric Medical Society.
- •Meeting the selection for HBO criteria as determined by transcutaneous oxygen measurements.
- •Willing and able to provide an informed consent for the study and related procedures.
排除标准
- •Lower extremity or foot ulcers of non-diabetic peripheral vascular disease, venous, lymphedematous or neoplastic etiology.
- •Having any condition or previous treatment that is known to be a contra-indicated for hyperbaric oxygen therapy.
- •Pregnant or lactating females.
- •Candidate with proven macro-vascular compromise who is not eligible for vascular intervention surgery.
- •Previous treatment with hyperbaric oxygen therapy.
研究组 & 干预措施
Treatment
HBOT
干预措施: HBOT (Other)
Treatment
HBOT
干预措施: Standard wound care (Behavioral)
Control
Standard wound care
干预措施: Standard wound care (Behavioral)
结局指标
主要结局
Change in wound size
时间窗: 4 years
The change of wound size at 4 weeks (granulation formation) as measured by the Silhouette three dimensional photography
次要结局
未报告次要终点