Assessing factors related to diabetic foot ulcers
Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes
This study is testing how different factors, like skin health and nerve function, affect the risk of developing foot ulcers in people with type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT03213093 on ClinicalTrials.gov |
What this trial studies
This study aims to prospectively evaluate various factors contributing to the development of diabetic foot ulcers (DFUs) in patients with type 2 diabetes. It focuses on the neurovascular response to non-noxious pressure and other elements such as skin vulnerability and peripheral neuropathy. Participants will undergo measurements of cutaneous microcirculation to better understand the pathogenesis of DFUs. The study includes individuals classified as 'Grade 0' to 'Grade 3' based on their risk of developing DFUs.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with type 2 diabetes and no active diabetic foot ulcers.
Not a fit: Patients with active diabetic foot ulcers or significant skin injuries on the tibia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for diabetic foot ulcers in at-risk patients.
How similar studies have performed: Other studies have explored similar factors in diabetic foot ulcer development, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Type 2 diabetic subject * Absence of active diabetic foot ulcer * Patients "Grade 0", "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by: * absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 0" * alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 1" * alteration of perception of Monofilament 10g at the level of the plantar arch associated with foot deformity and / or an arteriopathy defined by the absence of perception of one of the two peripheral pulses for the "grade 2" * History of diabetic foot ulcer for the "grade 3" * Signature of consent to participate in the study Exclusion Criteria: * Chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day * Pregnancy * Congenital methemoglobinemia. * Porphyria * Skin injured on the tibia, whatever the lesion * Recent major cardiovascular history (less than 3 months) * Severe renal disease (serum creatinine\> 300 μmol.l-1)
Where this trial is running
Pierre-Bénite
- service d'endocrinologie, Centre Hospitalier Lyon Sud — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Julien Vouillarmet
- Email: julien.vouillarmet@chu-lyon.fr
- Phone: 4-78-86-14-89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.