Comparative study between Minimal Invasive Metatarsal Osteotomy MIMO vs debridement dressing offloading cast DDO for plantar diabetic forefoot ulcer PDFU A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To evaluate the healing of ulcer in both groups
研究概览
简要总结
Public Title A study comparing two treatments minor bone surgery versus dressing and cast for healing diabetic foot ulcers in the front of the foot
Scientific Title Comparative study between Minimal Invasive Metatarsal Osteotomy MIMO versus Debridement Dressing and Offloading Cast DDO for Plantar Diabetic Forefoot Ulcer PDFU A Randomised Controlled Trial
Health Condition or Problem Studied Plantar diabetic forefoot ulcer in patients with diabetes mellitus
Intervention Group A Minimal Invasive Metatarsal Osteotomy MIMO Group B Debridement Dressing and Offloading Cast DDO
Primary Outcome Rate of ulcer healing defined as complete epithelialization without infection or drainage assessed up to 24 weeks
Secondary Outcomes Time to complete ulcer healing Recurrence rate of ulcer within 6 months Functional outcome measured by EFAS Score Foot Function Index and Manchester Oxford Foot Questionnaire
Study Design Randomized Controlled Trial Parallel group Superiority design Randomization by computer generated sequence with Serially Numbered Opaque Sealed Envelope method
Sample Size 52 participants total 26 in each group adjusted for 10 percent loss to follow up
Study Duration October 2025 to October 2027 including 6 month follow up
Study Site Department of Orthopaedics and Department of Surgery AIIMS Bibinagar Hyderabad Telangana India
Indian Status Not Yet Recruiting
Global Status India
Primary Sponsor All India Institute of Medical Sciences AIIMS Bibinagar Hyderabad Telangana India
Principal Investigator Dr Vishal Kumar Junior Resident Department of Orthopaedics AIIMS Bibinagar Hyderabad Telangana India
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 70 years with Wagners classification grade one and two diabetic ulcer under metatarsal head A single plantar ulcer at the level of metatarsal heads one to five Patients who consent to the study.
排除标准
- •Patients with evidence of osteomyelitis or cellulitis or systemic infections & sepsis Lack of palpable pedal pulses or ankle brachial pressure index less than 0 point 7 and known cases of PVD Pregnant or lactating women History of previous major foot surgeries on the same foot for any tumour or trauma Congenital or aquired foot and ankle deformities causing altered biomechanics of foot.
结局指标
主要结局
To evaluate the healing of ulcer in both groups
时间窗: 4,8,12 weeks
次要结局
- To compare ulcer recurrence within six months between minimal invasive metatarsal osteotomy MIMO vs debridement dressing and offloading cast DDO for plantar diabetic forefoot ulcer(To compare time for healing of ulcer in both the groups)
研究者
vishal kumar
AIIMS bibinagar