DiabeticMIS1: Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

Sponsor

University of Padova (Other)

Overall Status

Unknown status

CT.gov ID

NCT03010215

Collaborator

(none)

Enrollment

Location

Arm

131

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

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)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

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

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.]