Clinical Evaluation of the Addition of DEBRICHEM® to the Routine Management of Chronic Diabetic Foot Wounds: an Open-label Randomized Controlled Trial (CHEMfoot Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 242
- 主要终点
- Proportion of patients with complete wound healing at 20 weeks
研究概览
简要总结
This multicenter, randomized controlled trial will evaluate the effectiveness and safety of DEBRICHEM®, a topical desiccant gel, when added to standard care for chronic diabetic foot wounds. Chronic diabetic foot ulcers affect up to 25% of people with diabetes and are associated with high risks of infection, hospitalization, amputation, and mortality. Biofilm formation plays a key role in wound chronicity and delayed healing. DEBRICHEM® is designed to chemically debride wounds by removing biofilm in a single topical application, potentially accelerating the healing process.
A total of 242 adult patients with chronic diabetic foot ulcers (≥4 weeks, 0.5-10 cm²) will be randomized to receive either conventional wound care plus a single application of DEBRICHEM® or conventional wound care alone. The primary endpoint is the proportion of patients achieving complete wound healing at 20 weeks. Secondary outcomes include wound size reduction, infection rates, pain, quality of life, sleep, healthcare resource use, and safety.
详细描述
Diabetic foot ulcers (DFU) are a severe complication of diabetes, affecting approximately 20-25% of patients during their lifetime and preceding up to 80% of lower-limb amputations. Chronic wounds are often associated with biofilm formation, which sustains inflammation, delays healing, and reduces the efficacy of mechanical debridement and systemic treatments. New approaches targeting biofilm could improve wound outcomes.
DEBRICHEM® is a CE-marked (Class IIb) medical device developed by DEBx Medical B.V. It is a red, semi-fluid desiccant gel that rapidly binds water molecules in biological material, thereby disrupting biofilm and necrotic tissue. The gel is applied topically for 60 seconds and then rinsed with saline, replacing conventional mechanical debridement. Previous case series and observational data suggest DEBRICHEM® may accelerate granulation and wound closure. However, no randomized controlled trial has yet demonstrated its clinical benefit in diabetic foot ulcers.
The CHEMfoot study is a prospective, open-label, randomized controlled trial conducted at six centers in France. Adults with type 1 or type 2 diabetes and chronic foot ulcers (≥4 weeks, 0.5-10 cm², Texas grade 0-IIC) will be randomized 1:1 to:
Intervention arm: single topical application of DEBRICHEM® plus standard wound care.
Control arm: standard wound care alone, including mechanical debridement and appropriate dressings.
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
- 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
- •Adults ≥18 years.
- •Diabetic foot ulcer (toe, dorsal, plantar, or lateral foot) persisting ≥4 weeks without improvement.
- •Requires debridement.
- •Wound size 0.5-10 cm².
- •Texas classification 0-IIC (controlled neuro-ischemic ulcers, localized infection only).
- •HbA1c ≤10% in last 3 months. Peripheral arterial disease controlled, no critical limb ischemia (toe pressure >50 mmHg OR ankle pressure >70 mmHg OR TcPO2 >30 mmHg).
排除标准
- •Allergy to DEBRICHEM® components.
- •Active malignancy, osteomyelitis, fasciitis, exposed cartilage.
- •Revascularization <4 weeks prior.
- •Systemic infection.
- •Pregnant or breastfeeding women.
- •Vulnerable populations under legal protection.
- •Participation in another clinical trial.
研究组 & 干预措施
DEBRICHEM® + conventional wound care
Single topical application of DEBRICHEM® (desiccant gel for chemical debridement) at inclusion, then standard wound dressings and care.
干预措施: DEBRICHEM® (Device)
Conventional wound care only
Mechanical debridement and wound dressing per standard of care
结局指标
主要结局
Proportion of patients with complete wound healing at 20 weeks
时间窗: 20 weeks
100% wound surface closure, complete re-epithelialization, and absence of exudate, confirmed by blinded investigator and adjudication committee review of wound photographs.
次要结局
- wound healing wk 8(week 8)
- wound healing week 12(12 weeks)
- Proportion of patients with ≥50% wound surface reduction(20 weeks)
- wound area change(20 weeks)
- Incidence of wound infection(20 weeks)
- Quality of Iife(20 weeks)
- Pain Score(20 weeks)
- Sleep quality(20 weeks)
- Safety by adverse event monitoring(20 weeks)
- health resources(20 weeks)
- treatment usability(20 weeks)