Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery (DiabeticMIS1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03010215
Recruitment Status : Active, not recruiting
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Information provided by (Responsible Party):
Carlo Biz, University of Padua

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) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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 : January 2010
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Change in clinical evaluation with SF-36 score [ Time Frame: From 1 month before the operation until study completion, an average of 2 years. ]
  3. Change in clinical evaluation with VAS [ Time Frame: From 1 month before the operation until study completion, an average of 2 years. ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03010215

Orthopaedic Clinic, Padua University
Padova, PD, Italy, 35128
Sponsors and Collaborators
University of Padua
Principal Investigator: Carlo Biz, MD University of Padua

Publications of Results:
Responsible Party: Carlo Biz, MD, Assistant Professor, University of Padua Identifier: NCT03010215     History of Changes
Other Study ID Numbers: DiabeticMIS01
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Age, Gender, Radiological and Clinica parameters and images.

Keywords provided by Carlo Biz, University of Padua:
Minimally Invasive Surgery
Percutaneous distal osteotomy
Distal Metatarsal Minimally-invasive Osteotomy (DMMO)
Percutaneous Tenotomy
Metatarsal bones

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Foot Deformities
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Endocrine System Diseases
Foot Diseases
Musculoskeletal Diseases
Pathologic Processes
Diabetic Angiopathies
Leg Ulcer
Skin Ulcer
Diabetes Complications
Diabetes Mellitus
Diabetic Neuropathies