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

This study has been withdrawn prior to enrollment.
(not enough recruitment)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00578890
First received: December 19, 2007
Last updated: September 14, 2012
Last verified: June 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Medical and Medical-surgical Management of Diabetic Foot Osteomyelitis

Resource links provided by NLM:

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 ]

Enrollment: 0
Study Start Date: June 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Other Name: Medical/surgical treatment versus medical treatment

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

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: Mathieu QUINTIN, Delegation of clinical research
ClinicalTrials.gov Identifier: NCT00578890     History of Changes
Other Study ID Numbers: P060218
Study First Received: December 19, 2007
Last Updated: September 14, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
diabetic foot
osteomyelitis

Additional relevant MeSH terms:
Osteomyelitis
Diabetic Foot
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
 Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 21, 2013