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

NCT ID: NCT00578890

Last Updated: 2012-09-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-06-30

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

Conditions

Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

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

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Delegation of clinical research

Principal Investigators

Agnès Hartemann-Heurtier, PHD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Other Identifiers

P060218

Identifier Type: -

Identifier Source: org_study_id