Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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Thirty-two patients with chronic diabetic foot ulcers (CDFUs) were treated by MIS between January 2010 and September 2016. Clinical evaluation was assessed pre-operatively, as well as at 3 months after surgery and at final follow-up, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale. The recurrence of the ulcers and complications were recorded. All the ulcers were evaluated with the University of Texas Diabetic Wound Classification. We used the radiological Maestro's criteria to evaluated the radiographs before and after the operation. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency. The global disability was evaluated with the Short Form Health Survey (SF-36) and the satisfaction's level with the Visual Analogue Scale (VAS). Statistical analysis was carried out using the Wilcoxon signed-rank test. Statistical significance was set at p < 0.05.

Official Title
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Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study

Conditions
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Diabetic Foot Ulcer, Diabetic Foot, Diabetic Foot Infection, Diabetic Foot Ulcer Neuropathic, Deformities Foot

Intervention / Treatment
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* Other: Distal Metatarsal Minimally invasive Osteotomy (DMMO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of DM; presence of a plantar CDFU, so not healed after 6 months of medical multidisciplinary treatment; HbA1c < 8,5%. Exclusion Criteria: congenital deformities of the foot; macroscopic signs of local infection of the soft tissues; alteration of CRP>150 mg/L; previous foot and ankle surgery; previous foot and ankle surgery; rheumatic, neurologic, infective, or psychiatric pathologies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Minimally Invasive Surgery (MIS)<br>Patients with plantar chronic diabetic foot ulcers will be treated by Distal Metatarsal Minimally invasive Osteotomy (DMMO). | Other: Distal Metatarsal Minimally invasive Osteotomy (DMMO)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale | Total between 0 to 100. | From 1 month before the operation until study completion, an average of 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological outcomes changes after surgical treatment | Evaluation of the Maestro Criteria and the bridging bone/callus formation. | Preoperative and at 3-6-12 months post-operative | 
| Change in clinical evaluation with SF-36 score |  | From 1 month before the operation until study completion, an average of 2 years. | 
| Change in clinical evaluation with VAS |  | From 1 month before the operation until study completion, an average of 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally Invasive Surgery, Percutaneous distal osteotomy, Distal Metatarsal Minimally-invasive Osteotomy (DMMO), Percutaneous Tenotomy, Forefoot, Metatarsal bones