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

Phase 4

Withdrawn

• Conditions: Diabetic Foot
• Interventions: Procedure: Medical/surgical treatment versus medical treatment

• Registration Number: NCT00578890
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Study Start: 2008-06
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Medical/surgical treatment versus medical treatment	-

Primary Outcome Measures

Name	Time	Method
no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing	12 months after healing

Secondary Outcome Measures

Name	Time	Method
amputation rate	before healing
healing time	end of study
ulcer relapse 12 months after healing	12 months after healing