Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-02-25 @ 2:37 AM
Study NCT ID:
NCT04081792
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2019-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Antibiotics for Operated Diabetic Foot Infections
Sponsor:
Balgrist University Hospital
Organization:
Study Overview
Official Title:
Optimization of the Surgical and Medical Management of Diabetic Foot Infections
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: