<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03010215</url>
  </required_header>
  <id_info>
    <org_study_id>DiabeticMIS01</org_study_id>
    <nct_id>NCT03010215</nct_id>
  </id_info>
  <brief_title>Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery</brief_title>
  <acronym>DiabeticMIS1</acronym>
  <official_title>Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Padova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the development of the control of DM and the great interest for the complications of&#xD;
      the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon.&#xD;
      Being frequently correlated to alteration of the plantar pressures, the surgery treatment is&#xD;
      recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve this&#xD;
      pathologic case.&#xD;
&#xD;
      The purpose of this longitudinal cross-sectional study was to evaluate radiographic and&#xD;
      surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis&#xD;
      of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic&#xD;
      through MIS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty-two patients with chronic diabetic foot ulcers (CDFUs) were treated by MIS between&#xD;
      January 2010 and September 2016. Clinical evaluation was assessed pre-operatively, as well as&#xD;
      at 3 months after surgery and at final follow-up, using the American Orthopaedic Foot and&#xD;
      Ankle Society (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale. The recurrence of the&#xD;
      ulcers and complications were recorded. All the ulcers were evaluated with the University of&#xD;
      Texas Diabetic Wound Classification. We used the radiological Maestro's criteria to evaluated&#xD;
      the radiographs before and after the operation. Also, the bridging bone/callus formation was&#xD;
      evaluated at the different radiographic follow-ups, while the articular surface congruency.&#xD;
      The global disability was evaluated with the Short Form Health Survey (SF-36) and the&#xD;
      satisfaction's level with the Visual Analogue Scale (VAS). Statistical analysis was carried&#xD;
      out using the Wilcoxon signed-rank test. Statistical significance was set at p &lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score change of the AOFAS Hallux metatarsophalangeal interphalangeal scale</measure>
    <time_frame>From 1 month before the operation until study completion, an average of 2 years.</time_frame>
    <description>Total between 0 to 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiological outcomes changes after surgical treatment</measure>
    <time_frame>Preoperative and at 3-6-12 months post-operative</time_frame>
    <description>Evaluation of the Maestro Criteria and the bridging bone/callus formation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinical evaluation with SF-36 score</measure>
    <time_frame>From 1 month before the operation until study completion, an average of 2 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinical evaluation with VAS</measure>
    <time_frame>From 1 month before the operation until study completion, an average of 2 years.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <condition>Diabetic Foot</condition>
  <condition>Diabetic Foot Infection</condition>
  <condition>Diabetic Foot Ulcer Neuropathic</condition>
  <condition>Deformities Foot</condition>
  <arm_group>
    <arm_group_label>Minimally Invasive Surgery (MIS)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with plantar chronic diabetic foot ulcers will be treated by Distal Metatarsal Minimally invasive Osteotomy (DMMO).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Distal Metatarsal Minimally invasive Osteotomy (DMMO)</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Minimally Invasive Surgery (MIS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of DM;&#xD;
&#xD;
          -  presence of a plantar CDFU, so not healed after 6 months of medical multidisciplinary&#xD;
             treatment;&#xD;
&#xD;
          -  HbA1c &lt; 8,5%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital deformities of the foot;&#xD;
&#xD;
          -  macroscopic signs of local infection of the soft tissues;&#xD;
&#xD;
          -  alteration of CRP&gt;150 mg/L;&#xD;
&#xD;
          -  previous foot and ankle surgery;&#xD;
&#xD;
          -  previous foot and ankle surgery;&#xD;
&#xD;
          -  rheumatic, neurologic, infective, or psychiatric pathologies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlo Biz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopaedic Clinic, Padua University</name>
      <address>
        <city>Padova</city>
        <state>PD</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Biz C, Fosser M, Dalmau-Pastor M, Corradin M, Roda MG, Aldegheri R, Ruggieri P. Functional and radiographic outcomes of hallux valgus correction by mini-invasive surgery with Reverdin-Isham and Akin percutaneous osteotomies: a longitudinal prospective study with a 48-month follow-up. J Orthop Surg Res. 2016 Dec 5;11(1):157. doi: 10.1186/s13018-016-0491-x.</citation>
    <PMID>27919259</PMID>
  </results_reference>
  <results_reference>
    <citation>Tamir E, Finestone AS, Avisar E, Agar G. Mini-Invasive floating metatarsal osteotomy for resistant or recurrent neuropathic plantar metatarsal head ulcers. J Orthop Surg Res. 2016 Jul 11;11(1):78. doi: 10.1186/s13018-016-0414-x.</citation>
    <PMID>27401772</PMID>
  </results_reference>
  <results_reference>
    <citation>Dayer R, Assal M. Chronic diabetic ulcers under the first metatarsal head treated by staged tendon balancing: a prospective cohort study. J Bone Joint Surg Br. 2009 Apr;91(4):487-93. doi: 10.1302/0301-620X.91B4.21598.</citation>
    <PMID>19336809</PMID>
  </results_reference>
  <results_reference>
    <citation>Henry J, Besse JL, Fessy MH; AFCP. Distal osteotomy of the lateral metatarsals: a series of 72 cases comparing the Weil osteotomy and the DMMO percutaneous osteotomy. Orthop Traumatol Surg Res. 2011 Oct;97(6 Suppl):S57-65. doi: 10.1016/j.otsr.2011.07.003. Epub 2011 Aug 27.</citation>
    <PMID>21873138</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Padova</investigator_affiliation>
    <investigator_full_name>Carlo Biz</investigator_full_name>
    <investigator_title>MD, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Minimally Invasive Surgery</keyword>
  <keyword>Percutaneous distal osteotomy</keyword>
  <keyword>Distal Metatarsal Minimally-invasive Osteotomy (DMMO)</keyword>
  <keyword>Percutaneous Tenotomy</keyword>
  <keyword>Forefoot</keyword>
  <keyword>Metatarsal bones</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Age, Gender, Radiological and Clinica parameters and images.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03010215
org study id: DiabeticMIS01
nct id: NCT03010215
lead sponsor: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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.
description: Total between 0 to 100.
measure: Radiological outcomes changes after surgical treatment
time frame: Preoperative and at 3-6-12 months post-operative
description: Evaluation of the Maestro Criteria and the bridging bone/callus formation.
measure: Change in clinical evaluation with SF-36 score
time frame: From 1 month before the operation until study completion, an average of 2 years.
measure: Change in clinical evaluation with VAS
time frame: From 1 month before the operation until study completion, an average of 2 years.
arm group label: Minimally Invasive Surgery (MIS)
arm group type: Other
description: Patients with plantar chronic diabetic foot ulcers will be treated by Distal Metatarsal Minimally invasive Osteotomy (DMMO).
intervention type: Other
intervention name: Distal Metatarsal Minimally invasive Osteotomy (DMMO)
description: 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 group label: Minimally Invasive Surgery (MIS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Carlo Biz, MD
role: Principal Investigator
affiliation: University of Padova
facility: 
country: Italy
citation: Biz C, Fosser M, Dalmau-Pastor M, Corradin M, Roda MG, Aldegheri R, Ruggieri P. Functional and radiographic outcomes of hallux valgus correction by mini-invasive surgery with Reverdin-Isham and Akin percutaneous osteotomies: a longitudinal prospective study with a 48-month follow-up. J Orthop Surg Res. 2016 Dec 5;11(1):157. doi: 10.1186/s13018-016-0491-x.
PMID: 27919259
citation: Tamir E, Finestone AS, Avisar E, Agar G. Mini-Invasive floating metatarsal osteotomy for resistant or recurrent neuropathic plantar metatarsal head ulcers. J Orthop Surg Res. 2016 Jul 11;11(1):78. doi: 10.1186/s13018-016-0414-x.
PMID: 27401772
citation: Dayer R, Assal M. Chronic diabetic ulcers under the first metatarsal head treated by staged tendon balancing: a prospective cohort study. J Bone Joint Surg Br. 2009 Apr;91(4):487-93. doi: 10.1302/0301-620X.91B4.21598.
PMID: 19336809
citation: Henry J, Besse JL, Fessy MH; AFCP. Distal osteotomy of the lateral metatarsals: a series of 72 cases comparing the Weil osteotomy and the DMMO percutaneous osteotomy. Orthop Traumatol Surg Res. 2011 Oct;97(6 Suppl):S57-65. doi: 10.1016/j.otsr.2011.07.003. Epub 2011 Aug 27.
PMID: 21873138
responsible party type: Principal Investigator
investigator affiliation: University of Padova
investigator full name: Carlo Biz
investigator title: MD, Assistant Professor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: Yes
ipd description: Age, Gender, Radiological and Clinica parameters and images.