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A mini-invasive surgery to treat resistant diabetic foot ulcers

Internal Offloading of Recalcitrant Diabetic Plantar Metatarsal Head Ulcers using Floating Metatarsal Osteotomy - FloMo

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030140
Enrollment
160
Registered
2020-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Floating Metatarsal Osteotomy for recalcitrant diabetic foot ulcers.: A mini invasive procedure called Floating Metatarsal Osteotomy, i.e. a small 3-4 mm incision made over the dorsum o

Sponsors

ESIC MEDICAL COLLEGE AND PGIMSR
Lead Sponsor
VIDHYA SREE S
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA: Male and female patients. Adults above 18 yrs. of age. Unilateral or bilateral. Plantar metatarsal ulcers of University of Texas/ Wagner grade 1 and grade 2. Grade 1: Superficial Diabetic Ulcer Grade 2: Ulcer extension Involves ligament, tendon, joint capsule or fascia. No abscess/ osteomyelitis. Resistant to conservative management for >3 months. Patients in whom infection has been treated. Patients willing for surgery.

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA: Any ulcer of grade higher than University of Texas/Wagner grade 1and grade 2. Patients with tendoachilles shortening as dictated by fixed plantar flexion. More than 2 metatarsal head or forefoot ulcers. Presence of charcots disease of foot. Presence of signs of ischemia dictated by ankle brachial index of less than 1. Presence of active infection â?? local and systemic signs. Local â?? purulence, cellulitis in the adjacent skin, malodor and tissue necrosis. Systemic â?? fever, leukocytosis. Any other systemic illnesses, prolonged steroid intake etc. likely to affect wound healing. Patients not willing for surgery.

Design outcomes

Primary

MeasureTime frame
To compare the technique of mini-invasive floating metatarsal osteotomy with that of conventional total contact cast in terms of the Diabetic Foot Ulcer Scale (DFS)Timepoint: at the time of admission and at 3 months.—

Secondary

MeasureTime frame
Rate of complete resolutionTimepoint: 6months;Rate of complicationsTimepoint: 6months;Rate of recurrenceTimepoint: 6months—

Countries

India

Contacts

Public ContactVIDHYA SREE S

ESIC MEDICAL COLLEGE AND PGIMSR

msviswesic@gmail.com9444419087

Outcome results

None listed

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