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85 active trials for Diabetic Foot Ulcer

SkinTE™ in the Treatment of Diabetic Foot Wounds

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds.

Start: April 2019

Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers

The overarching purpose of this study is to investigate the impact that exercise, as delivered through a medically supervised, outpatient cardiac rehabilitation program, has on the wound healing process in Type 2 diabetics having foot ulcers classified as being Wound, Ischemia, foot Infection (WIfI) stage 2 or lower. The criterion reference measure of diabetic foot ulcer wound healing is be the time required to reach the maturation phase of the wound healing cascade (wound closure without drainage).

Start: March 2021

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

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 (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 hypnosis intervention, in order to check its effectiveness; as well as the perspectives of informal caregivers on this adjuvant therapy. Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic ulcers active 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 with patients with DFU that benefited from the hypnosis sessions and to 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.

Start: February 2019

Implementation of Telemedicine for Patient With Lower Extremity Wounds

The objective of this study is to determine if patients with lower extremity wounds in rural communities who undergo specialty referral through telemedicine have expedited care compared to patients who are treated through standard in person referral.

Start: February 2020

Safety and Efficacy of the Noxsano Wound Care Bandage

This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity ulceration and/or arterial insufficiency lower extremity ulceration.

Start: August 2019

Smart Boot Use to Measure Offloading Adherence

The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed. The investigators will look at three groups of participants: the first group will wear a boot that can't be taken off. The second group will wear a boot that can be taken off, and they will get counseling about how important it is to follow instructions as to how often and when to wear the boot. The third group will wear a "smart" boot, which will interact with the person through a smart watch and smart phone, and give them direct feedback about how they are doing with following their boot wearing prescription. The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.

Start: May 2021

Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)

This pilot study wants to determine to which extent SPCCT allows obtaining images with improved quality and diagnostic confidence when compared to standard Dual Energy CT (DECT), both with and without contrast agent injection. Depending on the anatomical structures/organs to be visualized during CT examinations, different scanning protocols are performed with quite variable ionizing radiation doses. Therefore, in order to obtain the most extensive and representative results of the improvement in image quality between SPCCT and DECT that will be performed CT imaging on several body regions and structures, including diabetic foot, diabetic calcium coronary scoring, adrenal glands, coronary arteries, lung parenchyma, kidney stones, inner ear, brain and joints

Start: January 2021

A Predictive Technology for Prevention of Diabetic Foot Ulcers

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.

Start: February 2021

Effect of Deferoxamine on Wound Healing Rate in Patients With Diabetes Foot Ulcers

Diabetic foot ulcer (DFU) is one of the most invalidating complication of diabetes and represents a big economic burden for the society. No specific therapy is available for diabetic foot ulcers.The aim of this study is to define a new approach for treatment of chronic diabetic wounds. Our concept is based on the improvement of the cellular reaction to hypoxia. It will address the transcriptional factor HIF-1 (Hypoxia inducible factor-1) which is the cellular sensor for oxygen and which is specifically repressed by hyperglycemia. The study will investigate the effect of local deferoxamine (0.66 mg/ml), the only known HIF-1 inducer, on the wound healing rate in patients with neuropathic diabetic foot ulcers. The primary objective of the study will be the reduction with >50% of the wound area after 12 weeks of treatment.

Start: August 2021

Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers

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.

Start: February 2021

Total Contact Soft Cast in Diabetic Foot Ulcers

To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.

Start: April 2021

Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?

The Surgical Outpatient Clinic at Molde Hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. This treatment is given by an interdisciplinary diabetic foot ulcer team. The standard treatment for diabetic foot ulcers is relief, a method with good results. Although the treatment as usual gives good results, the team wants to optimize this treatment. By using custom felt relief for each patient, the treatment period might be reduced considerably. The aim of this study is therefore to investigate whether custom felt relief gives shorter processing time compared to standard relief treatment.

Start: October 2019

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

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.

Start: April 2021

miR-200b & miR-21 in Diabetic Wounds

This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to wound healing in diabetic patients and also to determine if ex vivo supplementation of miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from NPWT sponges from diabetic wounds. This study will enroll 124 (60 in the miR-200b arm and 64 in the miR21 arm) Diabetic Wound patients who have wound tissue oxygenation adequate to support wound healing and will be in the study for 14 weeks that includes 4 study visits.

Start: August 2019

Preventing Diabetic Foot Ulcers Through Cleaner Feet

Foot complications are among the most serious and costly complications of diabetes. People with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes. Amputation of all or part of foot is usually preceded by a foot ulcer, which became infected. This is a clinical trial to test the effectiveness of a topical antiseptic, chlorhexidine, for daily foot cleaning on the recurrence of diabetic foot ulcers in Veterans with a recent history of a foot ulcer.

Start: January 2019

The Mount Sinai Diabetic Foot Ulcer Prospective Trial

The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all. They sometimes become infected and require antibiotic therapy, debridement and amputation. The investigators normally take care of a diabetic foot ulcer with a combination of local wound care, surgical debridement if necessary, antibiotics if there is an infection, and reduction of pressure on the area of the foot with the ulcer. The investigators observed that some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the leg. This blockage results in pressure within the leg veins leading to swelling in the legs which may also prevent healing of the diabetic foot ulcer. This study will investigate whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results of this study could result in a new treatment that will allow future patients with diabetic foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine whether stent placement is helpful, the researchers will have to randomize each patient. In other words, to reduce bias, patients will be assigned either to a group receiving a stent or to a group not receiving a stent. Every patient in both groups will receive the standard of care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound examination of the legs. The standard of care for a diabetic foot ulcer may include local wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the foot.

Start: April 2018

Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Wagner Grade II Foot Ulcers, compared to placebo therapy.

Start: August 2020

Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.

This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.

Start: July 2018

Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Foot Ulcers

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.

Start: January 2019

The Feasibility of a Facebook Group-based Program for Foot Self-management Support of Adults With Diabetes in Canada

The primary objective of this study is to examine the feasibility of a Facebook group-based program to support adults with diabetes in their foot self-care and prevention of foot ulcers. The sub-objectives are: 1. To determine the recruitment and retention rate of participants in the study. 2. To assess the acceptability of the Facebook group program among participants. 3. To determine the frequency and pattern of engagement by the participants within the Facebook group platform. 4. To determine the participants' level of compliance with the intervention in terms of engagement. 5. To determine the amount of time involved in engaging and monitoring activities of the participants in the Facebook group platform by the administrator or facilitators. 6. To determine the efficacy of the Facebook group program and how it works to improve foot self-care outcomes, foot health status, and quality of life of adults with diabetes.

Start: March 2021