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Foot Ulcer clinical trials

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NCT ID: NCT04892771 Completed - Diabetic Foot Clinical Trials

Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer

Pied-REM
Start date: May 20, 2021
Phase:
Study type: Observational

To evaluate the benefit of multidisciplinary specific follow-up of patients with a healed diabetic foot ulcer at the rate of two annual consultation on wound recurrence.

NCT ID: NCT04829812 Completed - Clinical trials for Peripheral Arterial Disease

Medical Compression in Patients With Chronic Wound and Peripheral Arterial Disease

COMPAD2
Start date: March 15, 2021
Phase:
Study type: Observational

Real-life practice survey of vascular specialist in France caring for patients with chronic wound for which compression treatment would be indicated and arterial disease of the lower limbs

NCT ID: NCT04817228 Completed - Diabetic Foot Ulcer Clinical Trials

A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers

Start date: April 21, 2021
Phase: Phase 2
Study type: Interventional

This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU). In addition, the pharmacology effect of EX-02 will be assessed. Lower leg ulcer size between 2 cm2 and 80 cm2 (surface area).

NCT ID: NCT04803708 Completed - Diabetic Foot Ulcer Clinical Trials

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

REVERSE
Start date: March 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers.

NCT ID: NCT04784650 Completed - Diabetes Mellitus Clinical Trials

The Prevalence of Foot Complaints/Problems and Ulcers in a Pre-dialysis Population

Start date: January 31, 2021
Phase: N/A
Study type: Interventional

Diabetes mellitus is one of the main causes of chronic kidney disease (CKD) and an increased risk of foot complications is seen in patients suffering from both DM and CKD. CKD and DM patients share a trilogy of risk factors that contribute to the development of foot ulcers. This trilogy consists of peripheral arterial disease (PAD), neuropathy and an increased susceptibility to infection with an impaired wound healing. Additionally, almost one quarter of adults with CKD have to cope with depression. The aim of our study is to determine the prevalence and types of foot problems in a pre-dialysis population, consisting of both DM and non-DM patients. If possible, risk factors will be determined. The detrimental effects of poor kidney function and foot problems on the quality of life and the general health status will be analyzed. A higher prevalence of PAD, peripheral neuropathy and DM are expected in patients with foot problems compared to those without.

NCT ID: NCT04769115 Completed - Diabetic Foot Ulcer Clinical Trials

A Predictive Technology for Prevention of Diabetic Foot Ulcers

Start date: February 24, 2021
Phase: N/A
Study type: Interventional

The DAPSHealth system employs a predictive technology for prevention of diabetic foot ulcers, and in Real Time, identifies diabetic patients who experience lower extremity trauma and vascular obstruction utilizing the science of temperature trending.

NCT ID: NCT04755647 Completed - Diabetic Foot Ulcer Clinical Trials

Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers

Start date: February 23, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of a nitric oxide releasing solution, delivered as a footbath, to act as an antimicrobial treatment for participants presenting with a diabetic foot ulcer.

NCT ID: NCT04753294 Completed - Diabetic Foot Ulcer Clinical Trials

Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems

ASOLO-CW
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

NCT ID: NCT04750837 Completed - Clinical trials for Platelet Rich Plasma

Platelet Rich Plasma and Diabetic Foot Ulcer

Start date: January 16, 2020
Phase: Phase 2
Study type: Interventional

In chronic diabetic foot ulcer, if the conventional dressing fails, new therapeutic options such as recombinant human growth factors and bioengineered skin substitutes may be beneficial, but the cost is a limiting factor. Autologous platelet rich plasma is a cost-effective method that enhances wound healing by promoting the healing process by local release of growth factors.

NCT ID: NCT04698720 Completed - Diabetes Mellitus Clinical Trials

Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Research suggests that psychological factors may play an important role in DFU healing. Relaxation and hypnosis seem to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular chronic wounds such as DFU. This study will evaluate the efficacy of relaxation and hypnosis, both with guided imagery, in DFU healing, physiological indicators (inflammatory, metabolic, oxidative stress, angiogenic, and miRNA biomarkers) of wound healing prognosis, and QoL, in patients with diabetic foot and a chronic ulcer. This study is a Randomized Controlled Study of a Psychological Intervention that aims to evaluate the efficiency of a muscle relaxation intervention with guided imagery (experimental group - EG1) compare to a hypnosis intervention with guided imagery (experimental group - EG2) and a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG). This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation and hypnosis interventions, in order to check its effectiveness; as well as the perspectives of informal caregivers on this adjuvant therapys. Participants must have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic active ulcers at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the four conditions - EG1, EG2, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted independently with patients that completed the relaxation, hypnosis, and placebo sessions, and with the informal caregivers who provided them the DFU care. The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.