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a Randomized Controlled Trial Comparing Medical and Medical-surgical Treatment in Diabetic Foot Osteomyelitis (DIPIOS)

Primary Purpose

Diabetic Foot

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Medical/surgical treatment versus medical treatment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring diabetic foot, osteomyelitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diabetes
  • neuropathy and a forefoot ulcer
  • osteomyelitis on X ray involving one or two contiguous ray
  • confirmed osteomyelitis on bone biopsy if a metatarsal head is involved
  • palpable distal pulses

Exclusion Criteria:

  • glomerular filtration rate < 30ml/min
  • whole bone destruction
  • contra-indication for off loading
  • ASAT or ALAT > three times normal rate
  • immunosuppressive drugs
  • Charcot foot on the concerned foot
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing

    Secondary Outcome Measures

    amputation rate
    healing time
    ulcer relapse 12 months after healing

    Full Information

    First Posted
    December 19, 2007
    Last Updated
    September 14, 2012
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00578890
    Brief Title
    a Randomized Controlled Trial Comparing Medical and Medical-surgical Treatment in Diabetic Foot Osteomyelitis
    Acronym
    DIPIOS
    Official Title
    Comparison of Medical and Medical-surgical Management of Diabetic Foot Osteomyelitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    not enough recruitment
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    June 2011 (Anticipated)
    Study Completion Date
    June 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Osteomyelitis is a frequent complication of diabetic foot ulcer. Several therapeutic strategies are used : medical treatment with antibiotics and foot offloading or surgical treatment consisting in the resection of infected bone and a shorter antibiotic course. The medical treatment risk is a longer healing time and a risk of bone infection relapse. The surgical treatment risk is the ulcer relapse because of the modification of the foot structure. These treatments need to be compared in terms of benefit/risk ratio. Our hypothesis is : 1) in the medical treatment group a 7 month mean healing time of and a 15% osteomyelitis recurrence rate;2) in the medical-surgical treatment group a 4 month mean healing time and a 10% osteomyelitis recurrence rate.
    Detailed Description
    The study aim is to compare the rate of therapeutic success of the secondary ostéite with a wound of the foot diabetic, obtained either by a single medical coverage(care), or by a medical surgical coverage(care). The therapeutic success being defined by the association of 1) the absence of local distribution(broadcasting) of the ostéite 2) the healing of the wound 3) in 12 months of the healing the absence of local recurrence of the ostéite

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot
    Keywords
    diabetic foot, osteomyelitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Medical/surgical treatment versus medical treatment
    Intervention Description
    A 12 week course antibiotics versus a limited resection of infected bone associated with a 4 week course antibiotics.
    Primary Outcome Measure Information:
    Title
    no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing
    Time Frame
    12 months after healing
    Secondary Outcome Measure Information:
    Title
    amputation rate
    Time Frame
    before healing
    Title
    healing time
    Time Frame
    end of study
    Title
    ulcer relapse 12 months after healing
    Time Frame
    12 months after healing

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diabetes neuropathy and a forefoot ulcer osteomyelitis on X ray involving one or two contiguous ray confirmed osteomyelitis on bone biopsy if a metatarsal head is involved palpable distal pulses Exclusion Criteria: glomerular filtration rate < 30ml/min whole bone destruction contra-indication for off loading ASAT or ALAT > three times normal rate immunosuppressive drugs Charcot foot on the concerned foot pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Agnès Hartemann-Heurtier, PHD
    Organizational Affiliation
    Assistance Publique - Hôpitaux de Paris
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    a Randomized Controlled Trial Comparing Medical and Medical-surgical Treatment in Diabetic Foot Osteomyelitis

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