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

Assistance Publique - Hôpitaux de Paris

Status and phase: Withdrawn; Phase 4

Conditions: Diabetic Foot

Treatments: Procedure: Medical/surgical treatment versus medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00578890

P060218

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

1

Experimental group

Treatment:

Procedure: Medical/surgical treatment versus medical treatment