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

NCT00578890 | Withdrawn Phase 4

• 1 other identifier: P060218
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Foot

Keywords

diabetic foot; osteomyelitis

Outcome Measures

Primary Outcomes (1)

• no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing

  12 months after healing

Secondary Outcomes (3)

• amputation rate

  before healing

• healing time

  end of study

• ulcer relapse 12 months after healing

  12 months after healing

Study Arms (1)

1

EXPERIMENTAL

Procedure: Medical/surgical treatment versus medical treatment

Interventions

Medical/surgical treatment versus medical treatment PROCEDURE

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

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Diabetic Foot; Osteomyelitis

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Agnès Hartemann-Heurtier, PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: June 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 17, 2012

Record last verified: 2011-06