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

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: NCT00578890
Recruitment Status : Withdrawn (not enough recruitment)
First Posted : December 21, 2007
Last Update Posted : September 17, 2012
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Procedure: Medical/surgical treatment versus medical treatment Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Medical and Medical-surgical Management of Diabetic Foot Osteomyelitis
Study Start Date : June 2008
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Procedure: Medical/surgical treatment versus medical treatment
A 12 week course antibiotics versus a limited resection of infected bone associated with a 4 week course antibiotics.

Primary Outcome Measures :
  1. no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing [ Time Frame: 12 months after healing ]

Secondary Outcome Measures :
  1. amputation rate [ Time Frame: before healing ]
  2. healing time [ Time Frame: end of study ]
  3. ulcer relapse 12 months after healing [ Time Frame: 12 months after healing ]

Information from the National Library of Medicine

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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:

  • 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

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): NCT00578890

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Agnès Hartemann-Heurtier, PHD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Mathieu QUINTIN, Delegation of clinical research Identifier: NCT00578890    
Other Study ID Numbers: P060218
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: June 2011
Keywords provided by Assistance Publique - Hôpitaux de Paris:
diabetic foot
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases