Clinical trial NCT04081792: Optimal Antibiotics for Operated Diabetic Foot Infections
Official title: Optimization of the Surgical and Medical Management of Diabetic Foot Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Infection
Surgical Wound
Antibiotic Side Effect
Infection
Keywords: diabetic foot; osteomyelitis; amputation; antibiotics
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diabetic foot infections or ischemia/necrosis with surgical amputation/disarticulation level in vicinity of MRI signs of infection
* At least two months of follow-up from hospitalization
* Patient signing to participate, including acceptance of local wound care, -off-loading and arterial re-vascularization (if clinically indicated).

Exclusion Criteria:

* At least 5 cm of distance between amputation level and infection.
* Any concomitant infection requiring more than 5 days of systemic antibiotic therapy
* Eventual osteosynthesis material not removed

Primary outcomes:
measure: Number of Participants with a clinical and microbiological remission of treated infection at 2 months
timeFrame: Through study completion, at 2 months
Secondary outcomes:
measure: Anatomical Amputation Level Determination by MRI
timeFrame: At study entry, Day O
measure: Rates of adverse events of antibiotic therapy
timeFrame: Through study completion, at 2 months
measure: Duration of wound healing time
timeFrame: Through study completion, at 2 months
measure: Numbers of Cost and resource reductions
timeFrame: Through study completion, at 2 months
measure: Scales of Patient's satisfaction
timeFrame: Through study completion, at 2 months
measure: Statistical evaluation of risk factors for failure of remission
timeFrame: 2 years
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital
state: Zurich
Study officials:
affiliation: Balgrist University Hospital, Zurich, Switzerland
name: Ilker Uçkay, PD MD
role: STUDY_DIRECTOR
References:
citation: Uckay I, Jornayvaz FR, Lebowitz D, Gastaldi G, Gariani K, Lipsky BA. An Overview on Diabetic Foot Infections, including Issues Related to Associated Pain, Hyperglycemia and Limb Ischemia. Curr Pharm Des. 2018;24(12):1243-1254. doi: 10.2174/1381612824666180302145754.
citation: Coster MC, Rosengren BE, Bremander A, Brudin L, Karlsson MK. Comparison of the Self-reported Foot and Ankle Score (SEFAS) and the American Orthopedic Foot and Ankle Society Score (AOFAS). Foot Ankle Int. 2014 Oct;35(10):1031-6. doi: 10.1177/1071100714543647. Epub 2014 Jul 11.
citation: Rossel A, Lebowitz D, Gariani K, Abbas M, Kressmann B, Assal M, Tscholl P, Stafylakis D, Uckay I. Stopping antibiotics after surgical amputation in diabetic foot and ankle infections-A daily practice cohort. Endocrinol Diabetes Metab. 2019 Feb 6;2(2):e00059. doi: 10.1002/edm2.59. eCollection 2019 Apr.
citation: Uckay I, Berli M, Sendi P, Lipsky BA. Principles and practice of antibiotic stewardship in the management of diabetic foot infections. Curr Opin Infect Dis. 2019 Apr;32(2):95-101. doi: 10.1097/QCO.0000000000000530.
citation: Gariani K, Lebowitz D, von Dach E, Kressmann B, Lipsky BA, Uckay I. Remission in diabetic foot infections: Duration of antibiotic therapy and other possible associated factors. Diabetes Obes Metab. 2019 Feb;21(2):244-251. doi: 10.1111/dom.13507. Epub 2018 Sep 21.
citation: Waibel F, Berli M, Catanzaro S, Sairanen K, Schoni M, Boni T, Burkhard J, Holy D, Huber T, Bertram M, Laubli K, Frustaci D, Rosskopf A, Botter S, Uckay I. Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials. Trials. 2020 Jan 8;21(1):54. doi: 10.1186/s13063-019-4006-z.