Optimal Antibiotics for Operated Diabetic Foot Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

643 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2025-03-01

Brief Summary

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Diabetic foot problems, especially infections (DFI), require multiple resources including iterative surgeries and amputations, long-lasting antibiotic therapies, education, off-loading and eventually revascularization and appropriate foot-ware. Treatment is complicated, multidisciplinary, and marked with a high risk of recurrences.

This is a retrospective and prospective cohort with side studies of pathologies and academic research questions that cannot be separated from each other.

The investigators establish a retro-and prospective cohort of diabetic foot problems (ambulatory and hospitalized patients) and perform side studies to reduce the incidence of complications, and to reduce recurrences of DFI, cost and adverse events related to therapies.

Cohort: Prospective and retrospective cohort of all diabetic foot problems with emphasis on surgical and infectious variables.

Trial 1 (Randomized trial on residual infection after amputation):

Determination of the level of amputation per MRI followed by a randomization concerning the duration of post-amputation systemic antibiotic therapy, if there is residual bone infection.

Trial 2 (Randomized trial on infection without amputation):

Determination of the duration of systemic antibiotic therapy in diabetic foot infections without Amputation of the infection.

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Detailed Description

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Trial 1: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 1 versus 4 days for post-amputation soft tissue infections; and between 1 versus 3 weeks if there is microbiologically proven residual bone infection/contamination in the proximal stump samples of the residual bone.

Trial 2: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 10 versus 20 days for post-debridement soft tissue infections; and between 3 versus 6 weeks for diabetic foot osteomyelitis post.-debridement (without amputation).

Conditions

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Diabetic Foot Infection Surgical Wound Antibiotic Side Effect Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Trial (Amputation) Soft tissue - short antibiotic arm

The intervention group consists of 1 day of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation.

Group Type EXPERIMENTAL