Less Infections for the Diabetic Foot

NCT03615807 | Completed Results

• 1 other identifier: n° 2016-01008
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, unblinded, single-centre study. After eventual surgical debridement (not amputation), patients will be randomized to receive 1 of 2 targeted antibiotic regimens, in the ratio 1:1. For diabetic toe osteomyelitis, the patients will be randomized between a 3 and a 6 week's arm, for soft tissue infections between 10 and 20 days. The final assessments used in the primary efficacy analysis will be obtained at the test-of-cure (TOC) visit approximately 60 days after treatment is stopped.

Conditions

Diabetic Foot

Keywords

diabetic foot infections; antibiotic reduction; osteomyelitis; soft tissue infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Clinical Failure

  Visual and dichotomous evaluation regarding the numbers of clinical recurrence/failure

  30-60 days

Secondary Outcomes (1)

• Number of Participants Experiencing Adverse Events Related to the Antibiotic Therapy

  30-60 days

Study Arms (2)

Short antibiotic arm

EXPERIMENTAL

10 days for soft tissue infections 3 weeks for osteomyelitis

Procedure: Surgical debridement (if needed); Diagnostic Test: Microbiological sampling; Procedure: Revascularisation (if needed).; Device: Off-loading; Behavioral: Patient's education and instructions; Procedure: Wound debridement; Drug: Antibiotic duration

Standard antibiotic arm

ACTIVE COMPARATOR

20 days for soft tissue infections 6 weeks for osteomyelitis

Procedure: Surgical debridement (if needed); Diagnostic Test: Microbiological sampling; Procedure: Revascularisation (if needed).; Device: Off-loading; Behavioral: Patient's education and instructions; Procedure: Wound debridement; Drug: Antibiotic duration

Interventions

Surgical debridement (if needed) PROCEDURE

Surgical debridement

Short antibiotic arm; Standard antibiotic arm

Microbiological sampling DIAGNOSTIC_TEST

Microbiological sampling

Short antibiotic arm; Standard antibiotic arm

Revascularisation (if needed). PROCEDURE

Revascularisation (if needed).

Short antibiotic arm; Standard antibiotic arm

Off-loading DEVICE

Off-loading by Special shoes

Short antibiotic arm; Standard antibiotic arm

Patient's education and instructions BEHAVIORAL

Patient's education and instructions by specialized nurses

Short antibiotic arm; Standard antibiotic arm

Wound debridement PROCEDURE

Regular wound debridement by specialized nurses

Short antibiotic arm; Standard antibiotic arm

Antibiotic duration DRUG

Systemic antibiotic duration according to the study arms

Short antibiotic arm; Standard antibiotic arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Diabetes mellitus
• Diabetic Foot Infections
• Surgical intervention to remove all necrotic tissue or tenotomy.
• Osteomyelitis limited to bone contact or cortical lesions in X-ray.

You may not qualify if:

• Implanted device.
• Amputation
• Destructive osteomyelitis
• Concomitant infections requiring more than 14 days of antibiotic therapy.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (3)

• Tone A, Nguyen S, Devemy F, Topolinski H, Valette M, Cazaubiel M, Fayard A, Beltrand E, Lemaire C, Senneville E. Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study. Diabetes Care 2015;38:302-307. Diabetes Care. 2015 Apr;38(4):735. doi: 10.2337/dc15-er04b. No abstract available.

  PMID: 25805867 RESULT

• Pham TT, Gariani K, Richard JC, Kressmann B, Jornayvaz FR, Philippe J, Lipsky BA, Uckay I. Moderate to Severe Soft Tissue Diabetic Foot Infections: A Randomized, Controlled, Pilot Trial of Post-debridement Antibiotic Treatment for 10 versus 20 days. Ann Surg. 2022 Aug 1;276(2):233-238. doi: 10.1097/SLA.0000000000005205. Epub 2021 Sep 15.

  PMID: 35623048 DERIVED

• Gariani K, Pham TT, Kressmann B, Jornayvaz FR, Gastaldi G, Stafylakis D, Philippe J, Lipsky BA, Uckay L. Three Weeks Versus Six Weeks of Antibiotic Therapy for Diabetic Foot Osteomyelitis: A Prospective, Randomized, Noninferiority Pilot Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1539-e1545. doi: 10.1093/cid/ciaa1758.

  PMID: 33242083 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Osteomyelitis; Soft Tissue Infections

Condition Hierarchy (Ancestors)

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; Infections; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Professor Ilker UCKAY
• Organization: Balgrist University Hospital

ilker.uckay@balgrist.ch

+41 44 386 37 05

Study Officials

• Ilker Uçkay, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med Ilker Uçkay

Model Details: Two prospected-randomized protocols

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: August 6, 2018
• Study Start: February 16, 2017
• Primary Completion: February 29, 2020
• Study Completion: March 31, 2020
• Last Updated: June 9, 2020
• Results First Posted: June 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)