Diabetic Foot
Conditions
Keywords
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 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
Interventions
PROCEDUREMedical/surgical treatment versus medical treatment
A 12 week course antibiotics versus a limited resection of infected bone associated with a 4 week course antibiotics.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing | 12 months after healing |
Secondary
| Measure | Time frame |
|---|---|
| amputation rate | before healing |
| healing time | end of study |
| ulcer relapse 12 months after healing | 12 months after healing |
Outcome results
None listed