Oxygen-enriched Oil-based Dressing: a New Option for Tunneling Post-surgical Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete ulcer healing
研究概览
简要总结
This study is a prospective randomized controlled pilot study evaluating the efficacy and safety of an OEOd-based wound dressing compared with standard wound care in patients with post-surgical diabetic foot ulcers. Participants were randomly assigned at enrollment to receive either the OEOd-based dressing or standard therapy. The primary outcome was complete ulcer healing at 16 weeks. Secondary outcomes included new infections, need for additional surgical debridement, re-hospitalization, and time to healing. The study was designed to provide preliminary estimates of treatment effect and feasibility to inform future larger randomized trials.
详细描述
This study was designed as a prospective randomized controlled pilot study to evaluate the efficacy and safety of an OEOd-based wound dressing compared with standard wound care in patients with post-surgical diabetic foot ulcers. Adult patients with diabetes mellitus presenting with a post-surgical foot ulcer were prospectively enrolled and randomly assigned at the time of enrollment to receive either the OEOd-based wound dressing or standard therapy, according to a simple random allocation procedure.
All patients received standard multidisciplinary diabetic foot care, including surgical management when indicated, infection control, off-loading, and metabolic optimization. The investigational intervention consisted of a topical OEOd-based wound dressing applied according to routine clinical practice.
The primary endpoint of the study was complete ulcer healing at 16 weeks, defined as full epithelialization of the target lesion without drainage. Secondary endpoints included the occurrence of new infections, the need for additional surgical debridement, re-hospitalization during follow-up, and time to healing, which was evaluated as an exploratory outcome.
Given the pilot nature of the study, no formal a priori sample size calculation was performed. The trial was intended to provide preliminary estimates of treatment effect and feasibility to inform the design of future larger randomized controlled studies.
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
- •Adults (≥18 years) with diabetes mellitus
- •Presence of a post-surgical diabetic foot ulcer
- •Eligibility for topical wound treatment
- •Ability to provide written informed consent
排除标准
- •Active malignancy
- •Severe systemic infection or sepsis
- •Known hypersensitivity to components of the wound dressing
- •Inability to comply with study procedures or follow-up
- •Participation in another interventional clinical study during the same period
研究组 & 干预措施
OEOd-Based Wound Dressing
Participants assigned to this arm received a topical OEOd-based wound dressing applied to post-surgical diabetic foot ulcers according to routine clinical practice, in addition to standard multidisciplinary diabetic foot care.
干预措施: OEOd-based wound dressing (Device)
standard wound care
Participants assigned to this arm received standard wound care for post-surgical diabetic foot ulcers according to institutional clinical practice.
干预措施: Standard of Care (Investigator Choice) (Other)
结局指标
主要结局
Complete ulcer healing
时间窗: 16 weeks
number of ulcers completely healed at 16 weeks
次要结局
- new infections(16 weeks)
- Additional surgical debridement(16 weeks)
- re-hospitalization(16 weeks)
- time to healing(16 weeks)
研究者
Alessia Scatena
Diabetologist
Ospedale San Donato