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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Diabetic Foot Foot Health Surgery

U.S. FDA Resources

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:	June 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 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

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	Recruiting
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

No publications provided

Responsible Party:	Delegation of clinical research ( Mathieu QUINTIN )
Study ID Numbers:	P060218
Study First Received:	December 19, 2007
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00578890 History of Changes
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

Anti-Bacterial Agents
Musculoskeletal Diseases
Endocrinopathy
Skin Ulcer
Diabetes Complications
Osteomyelitis
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:

Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Infection
Bone Diseases
Bone Diseases, Infectious

Diabetic Angiopathies
Musculoskeletal Diseases
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Osteomyelitis
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on September 10, 2009