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a Randomized Controlled Trial Comparing Medical and Medical-Surgical Treatment in Diabetic Foot Osteomyelitis (DIPIOS)
This study is currently recruiting participants.
Study NCT00578890   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: December 19, 2007   Last Updated: February 11, 2009   History of Changes

December 19, 2007
February 11, 2009
June 2008
April 2011   (final data collection date for primary outcome measure)
no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing [ Time Frame: 12 months after healing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00578890 on ClinicalTrials.gov Archive Site
  • amputation rate [ Time Frame: before healing ] [ Designated as safety issue: No ]
  • healing time [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • ulcer relapse 12 months after healing [ Time Frame: 12 months after healing ] [ Designated as safety issue: No ]
Same as current
 
a Randomized Controlled Trial Comparing Medical and Medical-Surgical Treatment in Diabetic Foot Osteomyelitis
Comparison of Medical and Medical-Surgical Management of Diabetic Foot Osteomyelitis

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.

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

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Diabetic Foot
Procedure: Medical/surgical treatment versus medical treatment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
146
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Agnès Hartemann-Heurtier, PHD 33142178051 agnes.heurtier@psl.aphp.fr
France
 
NCT00578890
Mathieu QUINTIN, Delegation of clinical research
P060218
Assistance Publique - Hôpitaux de Paris
 
Principal Investigator: Agnès Hartemann-Heurtier, PHD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
January 2009

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