Midfoot Fusion Bolt (MFB) in the Early Stage of Diabetic-neuropathic Charcot Feet

This study has been terminated.
(The study was stopped because there were not enough eligible patients to complete the study.)
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01079637
First received: March 1, 2010
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

Randomized clinical trial (RCT) to compare treatment failure rates of surgical arthrodesis with MFB against cast treatment in patients suffering from early stage Charcot neuroarthropathy (CN) of the midfoot (Sella and Barrette stages 0, 1 or 2) within the first 2 years after initial treatment. Treatment failure is defined as the occurrence of one or more of the following: 1. Amputation, 2. Occurrence of ulcer or worsening of existing ulcer, 3. Surgical intervention for correction of deformity after initial treatment. The secondary aims are to compare foot function, radiologic outcome, quality of life, complications and foot temperature between the two groups.


Condition Intervention
Diabetes Mellitus 1 or 2
Midfoot Charcot Neuroarthropathy
Procedure: Surgery with Midfoot Fusion Bolt
Procedure: Cast treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Midfoot Fusion Bolt (MFB). A Randomized Controlled Multicenter Study to Assess the Effectiveness of Surgical Treatment With Midfoot Fusion Bolt in the Early Stage of Diabetic-neuropathic Charcot Feet

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • treatment failure rate [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

    Treatment failure is defined as the occurrence of one or more of the following:

    1. Amputation
    2. Occurrence of ulcer or worsening of existing ulcer (according to Wagner classification)
    3. Surgical intervention for correction of deformity after initial treatment


Secondary Outcome Measures:
  • Foot function [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Foot and ankle ability measure score and standard Range of motion measurements.

  • Radiologic outcome [ Time Frame: baseline, 12 weeks, 12 months ] [ Designated as safety issue: No ]
    Weightbearing or simulate lateral and AP x-Rays of both feet will be taken. Talus-first metatarsal and Calcaneus-fifth metatarsal angle will be measured.

  • Quality of life [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    EuroQoL5 questionnaire

  • Rate of complications [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Foot temperature [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Diabetica Solutions thermometer


Enrollment: 1
Study Start Date: May 2010
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Midfoot Fusion Bolt Procedure: Surgery with Midfoot Fusion Bolt
Surgery with Midfoot Fusion Bolt
Experimental: Cast treatment Procedure: Cast treatment
Cast treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Patients with Diabetes Mellitus Type I or II
  • CN stages 0, 1 or 2 of the midfoot (Sella and Barrette classification)
  • Willingness and ability to participate in the study follow-up according to the protocol
  • Ability to understand and read local language at elementary level
  • Signed informed consent

Exclusion Criteria:

  • Legal incompetence
  • Previous Charcot foot on the affected side
  • Active osteomyelitis in the affected foot
  • Above knee amputation on the contralateral side
  • Patient health status not adequate for surgery
  • Active malignacy
  • Severe peripheral arterial disease (ankle-brachial index <0.7 or absent digital waveforms on Doppler)
  • Ulcer grade 2 or more on the Wagner classification system
  • Alcohol or drug abuse
  • Life-threatening co-morbidities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079637

Locations
Germany
Dept. of Trauma and Reconstructive Surgery, University of Rostock
Rostock, Germany, 18055
Sponsors and Collaborators
AO Clinical Investigation and Documentation
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01079637     History of Changes
Other Study ID Numbers: MFB 2010
Study First Received: March 1, 2010
Last Updated: May 15, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by AO Clinical Investigation and Documentation:
Sella and Barrete Stage 0 1 or 2

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014