a Randomized Controlled Trial Comparing Medical and Medical-Surgical Treatment in Diabetic Foot Osteomyelitis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetic Foot	Procedure: Medical/surgical treatment versus medical treatment	Phase IV

MedlinePlus related topics:

Antibiotics Diabetic Foot Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Comparison of Medical and Medical-Surgical Management of Diabetic Foot Osteomyelitis

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing [ Time Frame: 12 months after healing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

amputation rate [ Time Frame: before healing ] [ Designated as safety issue: No ]
healing time [ Time Frame: end of study ] [ Designated as safety issue: No ]
ulcer relapse 12 months after healing [ Time Frame: 12 months after healing ] [ Designated as safety issue: No ]

Estimated Enrollment:	146
Study Start Date:	January 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: 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.

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diabetes
neuropathy and a forefoot ulcer
osteomyelitis on X ray involving only one METATARSI head or one metatarsi-phalangeal joint or the hallux proximal interphalangeal joint
confirmed osteomyelitis on bone biopsy
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578890

Contacts


Contact: Agnès Hartemann-Heurtier, PHD	33142178051	agnes.heurtier@psl.aphp.fr

Locations


France
	Hopital la Pitié Salpétriere
	Paris, France, 75013
	Contact: Agnès HARTEMANN - HEURTIER, PHD +33(0)1 42 17 80 51 agnes.heurtier@psl.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators


Principal Investigator:	Agnès Hartemann-Heurtier, PHD	Assistance Publique - Hôpitaux de Paris

More Information

Responsible Party:	Delegation of clinical research ( Mathieu QUINTIN )
Study ID Numbers:	P060218
First Received:	December 19, 2007
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00578890
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

diabetic foot

osteomyelitis

Study placed in the following topic categories:

Foot Ulcer

Diabetic Neuropathies

Skin Diseases

Ulcer

Vascular Diseases

Diabetes Mellitus

Endocrine System Diseases

Bone Diseases

Diabetic Angiopathies

Musculoskeletal Diseases

Endocrinopathy

Skin Ulcer

Diabetes Complications

Osteomyelitis

Diabetic Foot

Leg Ulcer

Additional relevant MeSH terms:

Cardiovascular Diseases

Infection

Bone Diseases, Infectious

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00578890