A Prospective, Open, Comparative, Randomized, Single-centre Study to Evaluate the Effect of Cadexomer Iodine Gel (IODOSORB) Compared to Standard Dressings (SOLOSITE) on Biofilm Disruption in Infected Diabetic Foot Ulcers (DFUs)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g])
研究概览
简要总结
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers.
◊ Trademark of Smith & Nephew
详细描述
IODOSORB gel is a cadexomer iodine product indicated for use in wet ulcers and wounds. As the use of IODOSORB has an anti-microbial effect and removes exudate continuously from the wound, a reduction in pain, odour, oedema, exudate, pus and debris, and microbial load including biofilm can be achieved, hence providing an environment conducive to the normal healing process. While evidence exists to support the use of IODOSORB in diabetic foot ulcers (DFUs) for the reduction of planktonic bacteria, little evidence exits for the effect of any topical therapy on non-planktonic or biofilm bacteria in-vivo. The aim of this study is to explore the effects of IODOSORB on biofilm in the wound, wound healing, and associated factors, such as odour, pain, and reduction of slough.
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
- None
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
- •The patient is able to understand the study and is willing to consent to the study.
- •The patient consents to the ongoing use of their de-identified photos by the Sponsor for purposes outside of this study.
- •The patient must be at least 18 years of age.
- •Males and females - provided they are not pregnant or lactating and if of reproductive age are using contraception.
- •The patient has presented with a DFU which, according to the clinical judgement of the Investigator, has a suspected biofilm
- •The patient has a DFU of Grade 1 or 2 according to the Meggit-Wagner scale. Grade 1 - Superficial ulcers limited to the dermis Grade 2 - Ulcers are transdermal with exposed bone or tendon, and without osteomyelitis or abscess formation
- •The patient's ulcer is suitable to be dressed with IODOSORB or SOLOSITE.
- •The patient has an ABPI >0.49; or toe pressure >50mmHg.
排除标准
- •Patients with a known history of poor compliance with medical treatment.
- •Patients who have participated in this study previously and who healed or were withdrawn.
- •Patients who are participating in any other clinical study.
- •Patients that have received continuous treatment with Iodosorb (on any wound) in the past 8 weeks (Iodosorb must not be continuously used for more 3 months) or whose reference ulcer has been treated with Iodosorb in the past 2 weeks.
- •Patients with a history of any thyroid disorders, e.g. Hashimoto's thyroiditis, Graves disease or non-toxic nodular goitre.
- •Patients undergoing treatment with mercurial antiseptics, taurolidine or lithium.
- •Patients with a known sensitivity to iodine or any of the other ingredients in IODOSORB, SOLOSITE or ALLEVYN Non-adhesive
- •Patients with severe renal impairment
- •Patients with an ulcer less than 3cm diameter.
- •Patients with an ulcer that is not exuding.
结局指标
主要结局
Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g])
时间窗: Baseline to Week 4
The primary variable was the within-patient change from Baseline in log\^10 biofilm-protected bacteria count from Baseline (initial assessment) to Week 4, as measured by curettage.
次要结局
- Ulcer Volume Measurements at Each Study Visit(Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days)
- Ulcer Area Measurements at Each Study Visit(Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days)
- Ulcer Depth Measurements at Each Study Visit(Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days)
- Percentage (%) Change in Ulcer Depth(Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days)
- Percentage (%) Change in Ulcer Volume(Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days)
- Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test(Baseline, Week 2, Week 4)
- Percentage (%) Change in Ulcer Area(Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days)