Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-economic Comparison of Daptomycin vs. Vancomycin Based Regimens
Summary
The purpose of the study is to evaluate the overall burden to the participant (economic, quality of life, patients satisfaction and freedom from side effects) when treating Gram positive infections of the foot in diabetic adults with daptomycin versus vancomycin.
Description
1. to compare the overall economic burden of therapy of a daptomycin vs. a vancomycin based antibiotic regimen for diabetic foot infections in the outpatient setting
2. to compare Quality of Life and patient satisfaction among recipients of a daptomycin vs. a vancomycin based regimen
3. to compare the safety and tolerance (adverse experiences) of daptomycin vs. vancomycin based regimens
4. to compare the efficacy (complete resolution of infection) of daptomycin vs. vancomycin based regimens
Study Design
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Diabetic Foot
Intervention
Cubicin, Vancomycin
Location
Infuscience
Annandale
Virginia
United States
22003
Status
Active, not recruiting
Source
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01133600
- Information obtained from ClinicalTrials.gov on July 24, 2011
Medical and Biotech [MESH] Definitions
Diabetic Foot
Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.
Diabetic Neuropathies
Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)
Foot Deformities, Acquired
Distortion or disfigurement of the foot, or a part of the foot, acquired through disease or injury after birth.
Vancomycin Resistance
Nonsusceptibility of bacteria to the action of VANCOMYCIN, an inhibitor of cell wall synthesis.
Tarsal Tunnel Syndrome
Entrapment of the distal branches of the posterior TIBIAL NERVE (which divides into the medial plantar, lateral plantar, and calcanial nerves) in the tarsal tunnel, which lies posterior to the internal malleolus and beneath the retinaculum of the flexor muscles of the foot. Symptoms include ankle pain radiating into the foot which tends to be aggravated by walking. Examination may reveal Tinel's sign (radiating pain following nerve percussion) over the tibial nerve at the ankle, weakness and atrophy of the small foot muscles, or loss of sensation in the foot. (From Foot Ankle 1990;11(1):47-52)
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PubMed Articles
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