Optimal Antibiotics for Operated Diabetic Foot Infections

NCT04081792 | Completed DMC

• 1 other identifier: DFI_Cohort
• Study Type: interventional
• Target: 643
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Infection; Surgical Wound; Antibiotic Side Effect; Infection

Keywords

diabetic foot; osteomyelitis; amputation; antibiotics

Outcome Measures

Primary Outcomes (1)

• Number of Participants with a clinical and microbiological remission of treated infection at 2 months

  Remission is the absence of any anamnesis or clinics for persistent or recurrent infection

  Through study completion, at 2 months

Secondary Outcomes (6)

• Anatomical Amputation Level Determination by MRI

  At study entry, Day O

• Rates of adverse events of antibiotic therapy

  Through study completion, at 2 months

• Duration of wound healing time

  Through study completion, at 2 months

• Numbers of Cost and resource reductions

  Through study completion, at 2 months

• Scales of Patient's satisfaction

  Through study completion, at 2 months

Study Arms (8)

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

EXPERIMENTAL

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

Procedure: Antibiotic therapy

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

ACTIVE COMPARATOR

The control group consists of 4 days duration of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation.

Procedure: Antibiotic therapy

1. Trial (Amputation) Bone - short antibiotic arm

EXPERIMENTAL

The intervention group consists of 1 week of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation.

Procedure: Antibiotic therapy

1. Trial (Amputation) Bone - long antibiotic arm

ACTIVE COMPARATOR

The intervention group consists of 3 weeks of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation.

Procedure: Antibiotic therapy

2.Trial (soft tissue infection) - short antibiotic arm

EXPERIMENTAL

The intervention group consists of 10 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection.

Procedure: Antibiotic therapy

2. Trial (soft tissue infection) - long antibiotic arm

ACTIVE COMPARATOR

The control group consists of 20 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection.

Procedure: Antibiotic therapy

2. Trial (osteomyelitis) - short antibiotic arm

EXPERIMENTAL

The intervention group consists of 3 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis.

Procedure: Antibiotic therapy

2. Trial (osteomyelitis) - long antibiotic arm

ACTIVE COMPARATOR

The control group consists of 6 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis.

Procedure: Antibiotic therapy

Interventions

Antibiotic therapy PROCEDURE

Postoperative randomizations regarding the duration of systemic antibiotics

1. Trial (Amputation) Bone - long antibiotic arm; 1. Trial (Amputation) Bone - short antibiotic arm; 1. Trial (Amputation) Soft tissue - long antibiotic arm; 1. Trial (Amputation) Soft tissue - short antibiotic arm; 2. Trial (osteomyelitis) - long antibiotic arm; 2. Trial (osteomyelitis) - short antibiotic arm; 2. Trial (soft tissue infection) - long antibiotic arm; 2.Trial (soft tissue infection) - short antibiotic arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 29508677 BACKGROUND

• 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.

  PMID: 25015390 BACKGROUND

• 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.

  PMID: 31008367 RESULT

• 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.

  PMID: 30664029 RESULT

• 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.

  PMID: 30129109 RESULT

• Zendeli F, Jedrusik A, Schaefer RO, Albrecht D, Betz M, Waibel FWA, Grober T, Kuhne N, Konneker S, Uckay I. Pathogen-Specific Risk for Iterative Surgical Debridement in Orthopedic Infections: A Prospective Multicohort Analysis. J Clin Med. 2025 Dec 10;14(24):8750. doi: 10.3390/jcm14248750.

  PMID: 41464652 DERIVED

• 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.

  PMID: 31915048 DERIVED

MeSH Terms

Conditions

Surgical Wound; Infections; Diabetic Foot; Osteomyelitis

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Wounds and Injuries; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ilker Uçkay, PD MD

  Balgrist University Hospital, Zurich, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: September 9, 2019
• Study Start: September 4, 2019
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: In 2022
• Access Criteria: Upon reasonable request upon the contact authors

Locations

CH (1)