Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery (DiabeticMIS1)
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|ClinicalTrials.gov Identifier: NCT03010215|
Recruitment Status : Active, not recruiting
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Despite the development of the control of DM and the great interest for the complications of the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon. Being frequently correlated to alteration of the plantar pressures, the surgery treatment is recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve this pathologic case.
The purpose of this longitudinal cross-sectional study was to evaluate radiographic and surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic through MIS.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer Diabetic Foot Diabetic Foot Infection Diabetic Foot Ulcer Neuropathic Deformities Foot||Other: Distal Metatarsal Minimally invasive Osteotomy (DMMO)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||December 2020|
Minimally Invasive Surgery (MIS)
Patients with plantar chronic diabetic foot ulcers will be treated by Distal Metatarsal Minimally invasive Osteotomy (DMMO).
Other: Distal Metatarsal Minimally invasive Osteotomy (DMMO)
Percutaneous dorsal incision at the level of the the distal part of the metatarsal bone, a Shannon burr is introduced at the level of metatarsal neck, with orientation of at approximately 45°, keeping the articular cartilage surface of the metatarsal head as reference point on the superior cortex.
In this position, under fluoroscopic control, the osteotomy is started following a distal-dorsal and proximal-plantar direction. In this way the metatarsal head moves proximally and dorsally reducing the metatarsal pressure on the plantar ulcer.
- Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale [ Time Frame: From 1 month before the operation until study completion, an average of 2 years. ]Total between 0 to 100.
- Radiological outcomes changes after surgical treatment [ Time Frame: Preoperative and at 3-6-12 months post-operative ]Evaluation of the Maestro Criteria and the bridging bone/callus formation.
- Change in clinical evaluation with SF-36 score [ Time Frame: From 1 month before the operation until study completion, an average of 2 years. ]
- Change in clinical evaluation with VAS [ Time Frame: From 1 month before the operation until study completion, an average of 2 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010215
|Orthopaedic Clinic, Padua University|
|Padova, PD, Italy, 35128|
|Principal Investigator:||Carlo Biz, MD||University of Padua|