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Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03010215
Acronym
DiabeticMIS1
Enrollment
40
Registered
2017-01-04
Start date
2010-01-31
Completion date
2020-12-31
Last updated
2017-01-04

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

Conditions

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

Keywords

Minimally Invasive Surgery, Percutaneous distal osteotomy, Distal Metatarsal Minimally-invasive Osteotomy (DMMO), Percutaneous Tenotomy, Forefoot, Metatarsal bones

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.

Interventions

OTHERDistal 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.

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scaleFrom 1 month before the operation until study completion, an average of 2 years.Total between 0 to 100.

Secondary

MeasureTime frameDescription
Radiological outcomes changes after surgical treatmentPreoperative and at 3-6-12 months post-operativeEvaluation of the Maestro Criteria and the bridging bone/callus formation.
Change in clinical evaluation with SF-36 scoreFrom 1 month before the operation until study completion, an average of 2 years.
Change in clinical evaluation with VASFrom 1 month before the operation until study completion, an average of 2 years.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026