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Diabetic Foot clinical trials

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NCT ID: NCT06124586 Recruiting - Diabetes Mellitus Clinical Trials

Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in PTA readiness ("immediate treatment," within 48h) has advantages over the "standard of care", i.e., an elective procedure ("elective PTA") in terms of clinical endpoints such as wound healing and infection according to WiFI classification, amputation rate, "major adverse limb events" (MALE=amputation, reintervention of the vessel, death), but also systemic complications such as "major adverse cardiac and cerebrovascular events" (MACE=myocardial infarction, stroke, death, restenosis, severe cardiac and cerebrovascular complications). Furthermore, the impact of PTA on the local wound microbiome remains unclear. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating pAVD by revascularization in DFS after initial diagnosis is unknown and has yet to be fully understood.

NCT ID: NCT06117436 Recruiting - Wound Heal Clinical Trials

Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients

Start date: October 19, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The growing incidence of DM can lead to the increased prevalence of diabetic foot complications, which have become a serious medical, social, and economic concern of global importance. this study aims to find a novel intervention that improve wound healing in diabetic foot ulcer to improve patients' quality of life, reduce amputation rate, and reduce the mortality rate among diabetic foot ulcer patients

NCT ID: NCT06111183 Recruiting - Diabetic Foot Ulcer Clinical Trials

Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY)

Start date: July 21, 2023
Phase: Phase 2
Study type: Interventional

This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.

NCT ID: NCT06104969 Recruiting - Diabetes Clinical Trials

DFC 004 Biomarkers for Active Diabetic Foot Ulcers

Start date: June 15, 2023
Phase:
Study type: Observational

This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions

NCT ID: NCT06092827 Not yet recruiting - Physical Inactivity Clinical Trials

Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration

DB-ACTIV
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Intervention in the form of a PA (physical activity) program combining aerobic, resistance, and flexibility exercises adapted for wearing a lower limb offloading device and limiting weight-bearing on the feet, with a duration of twelve (12) weeks, consisting of two supervised sessions and one unsupervised home session per week.

NCT ID: NCT06084052 Completed - Diabetic Foot Clinical Trials

Path Active; Safety and Tolerability Study

PASTS
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Path Active™ comprises a pair of monitoring insoles which measure parameters associated with foot ulceration in diabetes: temperature and pressure. The insoles are linked via an app to the wearer's mobile phone and also to a clinical dashboard so that both wearer and clinician are alerted to early signs of skin damage on the foot so that immediate preventive action can be taken. The study will assess safety and tolerability of Path Active™ in 10 users, who have been assessed as having a 'high risk' of foot ulceration, over a period of 7 days.

NCT ID: NCT06079008 Completed - Diabetic Foot Clinical Trials

The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients

Start date: June 1, 2016
Phase:
Study type: Observational

The goal of this observational study is to learn about the association between cardiac valve calcification and the 1-year mortality after lower-extremity amputation in diabetic patients. Diabetic patients requiring lower-extremity amputation were retrospectively studied. Preoperative detailed anamnesis was taken. Cardiac valve calcification was assessed using echocardiography at baseline. One-year follow-up was conducted and included clinical visits, hospital record assessment, and telephone reviews to obtain the survival status of patients. Researchers compare the survival group to the mortality group to study the relationship between the cardiac valve calcification and mortality.

NCT ID: NCT06067022 Completed - Diabetic Foot Ulcer Clinical Trials

Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers

Start date: January 5, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this observational study is to investigate the effects of the type, area and duration of ulceration on jaw pain, mandibular function limitation, TMD and swallowing in individuals with diabetic foot ulcers.The main questions it aims to answer are: - Does the change in foot structure due to diabetic foot ulcer have an effect on the temporomandibular jointand swalloving? - What are the determinants of tempomandibular dysfunction in individuals with diabetic foot ulcers? Participants (both groups) will be evaluated for quality of life, jaw functionality, mandibular dysfunction, oropharyngeal swallowing disorder, pain and diabetes complications.

NCT ID: NCT06066801 Recruiting - Clinical trials for Subjects With Diabetes and DFU With a Suspicion of DFO

Bedside Bone Biopsy in Diabetic Foot Osteomyelitis

BOLBOC
Start date: March 14, 2024
Phase: N/A
Study type: Interventional

During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. Diabetic foot osteomyelitis (DFO), which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and their susceptibility. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons: lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive. To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by diabetologists at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete healing at 12 months compared to conventional surgical or radiological bone biopsies. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside BB versus conventional bone biopsy in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non-inferior to conventional bone biopsy in DFO and can be used as a simpler alternative procedure to document DFO

NCT ID: NCT06062576 Not yet recruiting - Diabetic Foot Clinical Trials

Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot

Start date: December 20, 2023
Phase: Phase 4
Study type: Interventional

Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. This study explored the possible indications and use methods of Yunnan Baiyao in different stages of Diabetic foot, and obtained Evidence-based medicine evidence of clinical efficacy. Obtain the discarded tissues of Diabetic foot patients in the treatment and control groups of Yunnan Baiyao after wound debridement, conduct Transcriptome (BulkRNA seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of Yunnan Baiyao.