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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Comparison of Medical and Medical-surgical Management of Diabetic Foot Osteomyelitis

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 Summary: 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
Sponsor: Assistance Publique - Hôpitaux de Paris

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • amputation rate [ Time Frame: before healing ]
  • healing time [ Time Frame: end of study ]
  • ulcer relapse 12 months after healing [ Time Frame: 12 months after healing ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: December 19, 2007
Date Started: June 2008
Date Completion: June 2011
Last Updated: September 14, 2012
Last Verified: June 2011