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

Diabetic Foot Clinical Trial

— DIPIOS  

Official title:

Comparison of Medical and Medical-surgical Management of Diabetic Foot Osteomyelitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00578890
• Other study ID #: P060218
• Status: Withdrawn
• Phase: Phase 4
• First received: December 19, 2007
• Last updated: September 14, 2012
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Osteomyelitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing		12 months after healing	No
Secondary	amputation rate		before healing	No
Secondary	healing time		end of study	No
Secondary	ulcer relapse 12 months after healing		12 months after healing	No