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

Tracking Information

First Received Date ^ICMJE

March 1, 2010

Last Updated Date

October 7, 2011

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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:

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01079637 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus 1 or 2
Midfoot Charcot Neuroarthropathy

Intervention ^ICMJE

Procedure: Surgery with Midfoot Fusion Bolt
Surgery with Midfoot Fusion Bolt
Procedure: Cast treatment
Cast treatment

Study Arms

Experimental: Midfoot Fusion Bolt
Intervention: Procedure: Surgery with Midfoot Fusion Bolt
Experimental: Cast treatment
Intervention: Procedure: Cast treatment

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

116

Completion Date

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Maja Schlittler, MSc

0041 44 200 24 55

maja.schlittler@aofoundation.org

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01079637

Other Study ID Numbers ^ICMJE

MFB 2010

Has Data Monitoring Committee

Responsible Party

( AO Clinical Investigation and Documentation )

Study Sponsor ^ICMJE

AO Clinical Investigation and Documentation

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

AO Clinical Investigation and Documentation

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP