View clinical trials related to Diabetic Foot Ulcer.
Filter by:The goal of this clinical trial is to assess the impact that the NanoSALV wound dressing can have on managing severe chronic wounds and feasibility for patients, providers, and health systems in different health care settings (community care, continuing care and in-patient care). The main questions it aims to answer are: 1. What is the cost-savings of using NanoSALV? 2. Do care providers perceive NanoSALV to be better, worse or the same as the standard of care in terms of usability and efficiency? 3. Does NanoSALV increase autonomy and competence of wound self-management for care providers/patients? 4. Were patients more satisfied, less satisfied or just as satisfied with NanoSALV compared to the standard of Care? 5. Does NanoSALV reduce healing time for chronic wounds compared to standard of care? The sequence and duration of the trial is as follows: - Required data will be collected at enrollment to provide a baseline (Day 0) measure. - The patient will receive standard of care treatment for four weeks with dressing changes as per the standard care pathway. - In the following four weeks the patient will receive the NanoSALV dressing treatment and dressing changes done every 48 - 72 hours as required. - Wound assessments will be done weekly with wound images captured by Aranz Medical's Silhouette Star 3D medical camera that digitally takes measurements. - A patient satisfaction survey will be collected post-control and post-intervention periods - One week after completing the study the patient/surrogate will be contacted or a survey link will be sent to them regarding adverse events and to see what wound dressing they continued to use. Semi-structured interviews and observations will be done with care providers/patients and healthcare professionals in the control period to explore the perspectives on the current state of chronic wound management, and in the intervention period to evaluate the perceptions on the usability of the intervention.
Diabetes affects 463 million population of the world. Diabetic foot is one of the complications of uncontrolled diabetes which can lead to amputation in 5- 24% of non-healing diabetic foot ulcers. Every 30 seconds a lower extremity is amputated in the world due to diabetes. This is a retrospective study conducted in Balochistan, Pakistan. In this study investigators explored the risk factor of amputation in diabetic patients. Baseline characteristics, clinical profile, and lab tests were retrieved retrospectively and presented in the forms of tables. Investigators compared the categorical variables in amputees vs non-amputees and analyzed associated risk factors of amputation.
Exercise studies with patients with diabetic foot ulcers are very few. In this disease group, since it is considered dangerous to put a load on the foot, a barrier has been placed between the patients and the exercise. With the study investigators plan to do, investigators will try to exercise in these patients in a controlled manner. Among the patients divided into 3 groups, the 1st group will apply the control group, the 2nd group will perform aerobic exercise, and the 3rd group will apply the exercises investigators have determined as the protocol group. 12 weeks, 2 sessions a week will be exercised with the help of a physiotherapist. Patients will be evaluated at baseline, at the end of week 4, at the end of week 8, and at the end.
Diabetic foot ulcers (DFU) are challenging to treat with complicated healing processes and require advanced wound care. Piscean collagen has the potential to promote the regenerative process while remaining cost-effective and with minimal side effects. In this study, the efficacy of a piscean collagen matrix dressing was compared with a standard dressing of saline-moistened gauze for wound healing in patients with neuropathic DFU. This is a double-blinded, randomised clinical trial.
The objective of this single-arm feasibility study is to investigate the safety and impact of the topical EPC Silver Wound Gel (EPC-123) in the management of diabetic foot ulcer wounds not progressing under the current standard of care.
Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be treated with MedCu wound dressings with copper oxide (COD) ("Copper Arm"). The study goals are to compare the efficacy, cost and convenience between MedCu Wound Dressings with Copper Oxide (COD) and Negative Pressure Wound Therapy of diabetic foot wounds.
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients. Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites. During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
The aim of this feasibility study is to evaluate a 12-week exercise intervention in people with an active diabetic foot ulcer through pre-defined research progression criteria (participant recruitment and retention, duration of the collection of outcome measures, adherence to the exercise programme, and adverse events), besides participant and physiotherapist feedback, self-reported outcomes and objective measurements in preparation for a potential future RCT. The primary study hypothesis is that exercise therapy for people with an active diabetic foot ulcer will have high participant recruitment and adherence to treatment and that it does not affect wound healing negatively.
Diabetic foot ulcers (DFU) are aggressive complications of diabetes mellitus (DM) and affect 25% of these patients. DFU are associated with a high risk of amputations and early mortality and significantly impact quality of life (QoL). The low-level laser therapy (LLLT) is an important approach for the treatment of DFU, however there is a lack of data on its influence on the QoL of patients with DFU. On the other hand, adherence to self-care is a factor closely related to QoL. Therefore, this study is justified by the need to understand the impact of LLLT on QoL and its relationship with self-care. Aim: To evaluate the quality of life of patients with diabetic foot ulcers treated with different doses of LLLT (GaAs) 904 nm and its association with aspects of adherence to self-care. Methods: This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomly assigned to the groups: control LLLT placebo (CG), LLLT 904 nm 10 J/cm² (LG1), LLLT 904 nm 8 J/cm² (LG2) and LLLT 904 nm 4 J/cm² (LG3). QoL data, percentage of healing and pain will be assessed before the start of the intervention, in 10th week and after one month to the end of intervention, self-care will be assessed before the start of the intervention and at the end of intervention. Eighty participants with DFU will be recruited who will receive intervention twice a week for up to 20 visits (10 weeks).