Proof of Concept Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Level of Applied Growth Factors in Chronic Wound Fluid
研究概览
简要总结
Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women aged ≥18 years
- •Ulcer size 1-64 cm²
- •Ulcer extends through both the epidermis and dermis, with no exposed tendon or bone
- •Ulcer duration >3 months
- •Ulcer located between and including the knee and ankle
- •For venous leg ulcers - Venous refilling time <25s on photoplethysmography or abnormal venous insufficiency Duplex scan
- •For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a haemoglobin A1C < 12%
- •Wounds have not been treated with Promogran in the previous 4 weeks
- •Patients able to give informed consent
排除标准
- •Ankle-brachial index <0.8
- •Ulcer with local or systemic signs of infection
- •Patients who have been previously treated with Becaplermin gel
- •Receiving corticosteroids or immune suppressants
- •History of autoimmune disease
- •Uncontrolled diabetes (baseline haemoglobin A1C > 12%)
- •Severe rheumatoid arthritis
- •Uncontrolled congestive heart failure
- •Malnutrition (albumin <2.5g/dL)
- •Unable to adhere to the protocol
- •Known sensitivities to the wound dressings used in the trial
- •A history of any previous malignancy
- •pregnant or lactating women
研究组 & 干预措施
Becaplermin/Placebo Dressing
Topical Becaplermin with a placebo wound dressing.
干预措施: Becaplermin (Biological)
Becaplermin/Promagran Dressing
Topical Becaplermin with a protease inhibitor wound dressing.
干预措施: Becaplermin (Biological)
Becaplermin/Promagran Dressing
Topical Becaplermin with a protease inhibitor wound dressing.
干预措施: Promagran Dressing (Device)
Becaplermin/Placebo Dressing
Topical Becaplermin with a placebo wound dressing.
干预措施: Placebo Dressing (Device)
结局指标
主要结局
Level of Applied Growth Factors in Chronic Wound Fluid
时间窗: 6 weeks
The levels of the growth factors applied to the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.
次要结局
- Protease Levels in Chronic Wound Fluid(6 weeks)
- Chronic Wound Healing at 4 Weeks(4 weeks)
- WOUNDCHEK Device Validity(6 weeks)
- Levels of Healing Biomarkers in Chronic Wound Fluid(6 weeks)