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Diabetic Foot clinical trials

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NCT ID: NCT05804565 Recruiting - Diabetic Foot Clinical Trials

MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation

MetaMet
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor wound healing, new infections and/or new ulcers. Research to date has focused on patient-related factors associated with poor wound healing (e.g. diabetes, lack of blood flow, poor kidney function). However, there is no research looking at the technical surgical aspects of the procedure, specifically how the toe bone is cut. For this feasibility study, we will recruit forty patients whom a consultant vascular surgeon has decided requires amputation of one-to-two adjacent toes. The participants will be randomised by a computer model into one of the two metatarsal transection methods (bone cutters or bone saw) and the rest of the procedure will be carried out in the standard fashion. Patients and assessors will be blinded to which transection method is chosen. Patients will undergo a post-operative foot x-ray to assess for bone fragments within 48 hours of surgery and another at six months to assess for bone healing. Patients will be asked to rate their pain in the post-operative period using the verbal rating score. Patients will be followed after discharge from hospital by their public health nurse, as is standard practice, with regular follow-up in the surgical outpatients to assess wound progress. Patients will be asked to rate their quality of life at six weeks and six months post-operatively. These assessments will be coordinated with their routine post-operative follow-up clinic appointments, so as not to inconvenience patients with supernumerary visits.

NCT ID: NCT05804097 Recruiting - Diabetic Foot Ulcer Clinical Trials

Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

DIONYSIUS
Start date: October 8, 2021
Phase: Phase 4
Study type: Interventional

The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral vascular disease. The main question is: - What is the difference is the major amputation rate between the study arms? Participants will be randomized to 20, 30 or 40 sessions of HBOT or a control group.

NCT ID: NCT05783115 Recruiting - Diabetic Foot Clinical Trials

Multicentre Study on Diabetic Foot Treatment

MSDFT
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

With a rapidly growing incidence rate and a high disability rate,The Diabetic Foot has long been difficult to treatment, which has caused a huge burden to patients and society. The blood supply disorder is one of the main reasons that lead to the morbidity and difficulty in healing of diabetes feet, but there is still a lack of particularly effective treatment to improve the blood supply of diabetes feet. Both transverse bone transport and bone marrow cell transplantation have shown some clinical effects. However, the difference in efficacy between the two has not been reported. In this study, investigators compared the therapeutic effects of these two methods on the healing of diabetes foot ulcers through a controlled clinical study.

NCT ID: NCT05772507 Recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)

Start date: August 22, 2023
Phase: N/A
Study type: Interventional

Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection

NCT ID: NCT05758545 Recruiting - Diabetic Foot Ulcer Clinical Trials

Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

Mavericks
Start date: June 19, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device at 12 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.

NCT ID: NCT05728411 Recruiting - Diabetic Foot Clinical Trials

Effectiveness of Remote Foot Temperature Monitoring

STOP
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a "smart" mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.

NCT ID: NCT05726006 Recruiting - Diabetic Foot Clinical Trials

Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults.

Start date: February 1, 2020
Phase:
Study type: Observational

Group B Streptococcus (GBS) infection is a potential aetiology of meningitis and septicemia in neonates, pregnant women and non-pregnant adults. Because the GBS disease burden is unknown in Malaysia, it is unlikely to receive much attention. This study aims to determine the prevalence of group B streptococcus isolated from non-pregnant adults, the Incidence, case-fatality ratio, antimicrobial susceptibility patterns, serotyping, genotyping and detection of the GBS virulence and pili genes from six major hospitals in Peninsular Malaysia.

NCT ID: NCT05716503 Recruiting - Diabetic Foot Clinical Trials

Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds

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

The aim of this thesis is to compare the efficacy of Vacuum assisted closure device versus conventional dressing before and after split thickness skin grafting in diabetic foot wounds.

NCT ID: NCT05692778 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Optimized Care of People With Diabetes and Foot Complication in Primary Care

Start date: January 1, 2020
Phase:
Study type: Observational

The goal of this observational study is to create and evaluate and new management, by using eHealth tools, to prevent diabetic foot ulcers. The main questions it aims to answer are: 1. Validation a. Is a method for foot assessment, that uses eHealth tools, valid regarding its usefulness? b. Is a method for foot assessment, that uses eHealth tools, reliable regarding the generated risk stratification? 2. Mapping 1. How do health care professionals and patients with diabetes experience that the future foot examination should be designed? 2. What experiences have health care professionals and patients with diabetes to use an eHealth tool supporting the annual foot examination? 3. Interviews - to use a paper format supporting a structured foot assessment a. How do health care professionals experience to use a structured foot form, in paper form? 4. Interviews - footwear a. What factors that influence how patients with diabetes choose their footwear? 5. Interviews - usability test of using an eHealth tool a. How could a digital eHealth tool be designed? b. How could a digital eHealth solution be implemented, managed and spread in public health care setting? i. Participants will: 1. fill in questionnaires 2. be interviewed 3. test eHealth solutions supporting the foot examination 6. Experiences of using an eHealth tool supporting the foot assessment a. How could a digital eHealth tool be designed? 7. Questionnaires regarding self-perceived quality of life, the experiences of the visit at the care unit, transportation to the care unit. a. Patients that visits care fills in a questionnaire regarding self-perceived quality of life (EQ-5D), a modified version of National Patient Survey, the diabetes questionnaire and a questionnaire regarding their travels and time for travels to and from the visit to the care unit. 8. Critical evaluation of complexity 1. Exists complexity in the development, test, management, spread and sustain of an eHealth tool supporting foot examination and self-care of the feet in diabetes. 2. How could a digital eHealth solution be implemented, managed and spread in public health care setting? 9. Long term effect a. What is the long-term effect of using an eHealth tools supporting a structured foot examination?

NCT ID: NCT05613985 Recruiting - Clinical trials for Diabetic Foot Infection

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

PHOTOFINISH
Start date: September 14, 2021
Phase: N/A
Study type: Interventional

The aim of this randomised, open-label, multicentre clinical trial is to evaluate the superiority of the treatment which foresees the addition of the system VULNOFAST® plus / VULNOLIGHT® to the Usual Care, versus the treatment with Usual Care alone, for the healing of chronic diabetic foot ulcer. VULNOFAST® plus is a sterile solution used in combination with a red light source VULNOLIGHT®. Usual Care is defined as procedures to apply to the foot ulcer, carried out in the order in which they are listed in the protocol.