Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03495349
Other study ID # 69HCL17_0850
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 5, 2018
Est. completion date January 10, 2021

Study information

Verified date June 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diabetes is a frequent and serious disease, with many complications. Diabetic foot ulcers are a frequent complication. Infection of diabetic foot ulcers is common, and requires heavy medical and/or surgical treatments. Antibiotherapy is one of the main options for the treatment of the diabetic foot ulcers, but it has many side effects. The aim of this study is to evaluate effectiveness and safety of medical treatments, in this population of patients.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date January 10, 2021
Est. primary completion date January 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults men and women - Followed for diabetic foot infection (grades 2 to 4 of IWGDF classification) - That accepted to take part in the study Exclusion Criteria: - Legal safeguard - Pregnant women - Patient that can't accept to take part in the study because can't be informed - Exclusive surgical treatment

Study Design


Intervention

Other:
safety and effectiveness of the usual treatments of diabetic foot infections
clinical and biological follow-up necessary to assess the safety and effectiveness of the medical treatments, MOS-SF survey (36-Item Short Form Survey) to study the quality of life.

Locations

Country Name City State
France Groupement Hospitalier Est Bron
France Centre Hospitalier Lyon Sud Pierre-Bénite

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods Effectiveness :
For soft tissue infections, remission is defined by the disappearance of any functional or physical sign of infection,
For osteomyelitis, remission is defined as the absence of clinical and /or radiological recurrence at the initial site one year after antibiotic therapy cessation.
1 year
Primary Occurrence of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods Occurrence of side effects:
All clinical and/or biological adverse events will be reported. The severity of any adverse events will be graded according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) from grade 1 (mild) to 5 (death).
Clinical adverse events included gastrointestinal disorders, skin eruption, pain, weight gain or loss Biological adverse events included impair kidney function, increase liver serum markers, anemia, low neutrophils count, thrombopenia.
1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04081792 - Optimal Antibiotics for Operated Diabetic Foot Infections N/A
Recruiting NCT05613985 - PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers N/A
Recruiting NCT03964571 - Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients N/A
Completed NCT03230175 - Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01) Phase 2
Completed NCT05616351 - Antibiotic Therapy in Infections of the Diabetic Foot Syndrome
Recruiting NCT05948592 - Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection Phase 2
Recruiting NCT04714411 - Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis
Completed NCT05243810 - EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers N/A
Recruiting NCT05610865 - Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers Phase 1
Recruiting NCT04450693 - Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) Phase 3
Recruiting NCT05369052 - Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI) Phase 3
Completed NCT02723539 - A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI Phase 1
Completed NCT04440839 - Implementation of Telemedicine for Patient With Lower Extremity Wounds N/A
Withdrawn NCT04289948 - Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes Phase 1/Phase 2
Completed NCT05564728 - Diabetes Footcare Companion App for Patients and Carers
Withdrawn NCT03354806 - Peripheral Analgesia in Painful Diabetic Neuropathy N/A
Completed NCT01590758 - Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers Phase 3
Completed NCT01594762 - Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers Phase 3
Active, not recruiting NCT05174806 - Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients Phase 2
Recruiting NCT04141787 - Ceftriaxone as Home IV for Staph Infections Phase 4