WithdrawnPhase 4

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

Stopped: not enough recruitment

0Started 2008-06

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 12 months after healing

Trial details

NCT IDNCT00578890

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

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