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

Study Overview
=================
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

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

Conditions
-----------------
Diabetic Foot

Intervention / Treatment
-----------------
* Procedure: Medical/surgical treatment versus medical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Medical/surgical treatment versus medical treatment<br>* A 12 week course antibiotics versus a limited resection of infected bone associated with a 4 week course antibiotics.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing |  | 12 months after healing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amputation rate |  | before healing | 
| healing time |  | end of study | 
| ulcer relapse 12 months after healing |  | 12 months after healing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic foot, osteomyelitis