View clinical trials related to Diabetic Foot.
Filter by:In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care. In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)
Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.
The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human subjects.
This study is an observational study. Collect cotton swabs of the surface skin are obtained from the non-diabetic and diabetic patients hospitalized in the Nanfang Hospital of Southern Medical University. The investigators use omics technology to identify the structure and functions of cutaneous microbiome, analyze the characteristics of the skin flora of diabetic patients, and find the difference in skin microbiota among diabetic patients with different risk levels for developing into diabetic foot. Then, the participants will be followed up to compare the incidence of ulcers among different groups. And the skin tissues discarded during surgical operations of non-diabetic and diabetes patients are collected for pathological examination. Finally, based on the results of 16S high-throughput sequencing, metagenomics, etc., specific flora could be extracted from human skin flora cotton swabs, and animal experiments are performed to explore the effect of skin micro-ecology on diabetic skin lesions. The investigators will explore in animal experiments to regulate the influence of skin micro-ecology on diabetic skin lesions through treatment methods such as different hypoglycemic drugs and probiotic emulsions.
Popliteal Sciatic nerve block is a regional technique that provides safe and reliable perioperative anesthesia and analgesia of lower leg and foot used in diabetic patients. Different additives have been used with local anaesthetics to achieve dense and prolonged block. Magnesium sulfate possesses analgesic properties owing to its effect on NMDA receptors.
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.
This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users. Approximately 65 subjects will be enrolled (calculated dropout range 20%) from at least 6-12 sites in Sweden. Subjects presented with chronic leg ulcers and chronic diabetic foot ulcers in need of debridement will be enrolled and receive application of ChloraSolv per clinical routine at treating site and in accordance with the ChloraSolv Instruction for Use for up to 24 weeks. Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. There will be two follow up visits in the investigation. The first follow up visit will take place at End of Treatment, as based on investigator judgement and clinical routine at the treating site, maximum 24 weeks post baseline per the IFU. After End of Treatment, subjects will continue in the investigation with wound management per clinical routine at the treating sites for 6 weeks. At 6 weeks post End of Treatment, subjects will attend a Follow-up visit to assess safety, wound status and relative change in wound size. Besides confirmation of the clinical performance and safety when used in a larger population the investigation also includes analysis of treatment period duration. Additionally, health economy parameters will be analyzed. The investigation will be monitored to confirm the already known precautions as well as identify new precautions and possible contraindications for the use of the device. Photography of the wound pre and post debridement will be performed to confirm wound size and amount of devitalized tissue in the wound.
Background: The wound dressings perform a crucial role in the cutaneous wounds' management due to their ability to protect wounds and promote dermal and epidermal tissue regeneration. Objective: the aim of the present study to evaluate the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing. Approach: Sixty patients with type-2 diabetes hospitalized for diabetic foot wound treatment were recruited from selected Surgical departments at Kasr Al-Aini university hospital.
This is a pilot case/control clinical study on a group of outpatients with diabetic foot lesions aiming to verify the efficacy and safety of the Blue light photobiomodulation therapy with EmoLED medical device, in addition to standard therapy compared to the standard therapy alone, evaluating the percentage of healed lesions (which have reached complete and lasting re-epithelialization), the evaluation of the healing time and reduction of the ulcerated area during the time of observation, the perception of pain and the quality of life of the enrolled patients. The aim of this study is therefore to determine any differences in outcome between the two groups considered and, in particular, if the therapy of the group being treated is more effective than the standard therapy in terms of percentage of healed lesions, healing time, and reduction of the ulcerated area, pain perception, and quality of life, and is at least as safe in terms of occurrence of adverse events.
The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area. A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA). This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands. The two arms are: 1. Control group: Standard wound care for 12 weeks or until healing, whichever occurs first; 2. Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first. The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site. For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day. Follow up (FU) will be performed at three timepoints for both arms: - FU1: 2 weeks after end treatment period - FU2: 12 weeks after end treatment period - FU3: 12 months after start treatment.