Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

Not Applicable

• Conditions: Diabetic Foot Ulcer; Diabetic Foot; Diabetic Foot Ulcer Neuropathic; Diabetic Foot Infection; Deformities Foot
• Interventions: Other: Distal Metatarsal Minimally invasive Osteotomy (DMMO)

• Registration Number: NCT03010215
• Lead Sponsor: University of Padova

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2016-09
• Study First Submitted: 2016-12-20
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-02
• Last Update Submitted: 2017-01-02
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally Invasive Surgery (MIS)	Distal Metatarsal Minimally invasive Osteotomy (DMMO)	Patients with plantar chronic diabetic foot ulcers will be treated by Distal Metatarsal Minimally invasive Osteotomy (DMMO).

Primary Outcome Measures

Name	Time	Method
Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale	From 1 month before the operation until study completion, an average of 2 years.	Total between 0 to 100.

Secondary Outcome Measures

Name	Time	Method
Radiological outcomes changes after surgical treatment	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	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.

Trial Locations

Locations (1)

Orthopaedic Clinic, Padua University; 🇮🇹 Padova, PD, Italy