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A study to compare two treatments surgery Minimal Invasive Metatarsal Osteotomy and dressing with off-loading cast for healing of forefoot ulcers in people with diabetes

Comparative study between Minimal Invasive Metatarsal Osteotomy MIMO vs debridement dressing offloading cast DDO for plantar diabetic forefoot ulcer PDFU A randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096352
Enrollment
52
Registered
2025-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: O- Medical and Surgical Health Condition 3: L898- Pressure ulcer of other site

Interventions

Intervention1: MIMO mimnimally invasive metatarsal osteotomy for diabetic fore foot unlcer over MT head plantar aspect vs dressind debridement offloading cast for some: give 1 2 cm incision over MT ma

Sponsors

AIIMS BBN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To evaluate the healing of ulcer in both groupsTimepoint: 4,8,12 weeks—

Secondary

MeasureTime frame
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 Timepoint: 6 months—

Countries

India

Contacts

Public Contactvishal kumar

AIIMS bibinagar

drranjithkumar@gmail.com9000536536

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026