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

NCT ID: NCT00578890

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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

Conditions

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Diabetic Foot

Keywords

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diabetic foot osteomyelitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Medical/surgical treatment versus medical treatment

Intervention Type PROCEDURE

A 12 week course antibiotics versus a limited resection of infected bone associated with a 4 week course antibiotics.

Interventions

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Medical/surgical treatment versus medical treatment

A 12 week course antibiotics versus a limited resection of infected bone associated with a 4 week course antibiotics.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Delegation of clinical research

Principal Investigators

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Agnès Hartemann-Heurtier, PHD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Countries

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France

Other Identifiers

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P060218

Identifier Type: -

Identifier Source: org_study_id