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40 active trials for Diabetic Foot

10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes

A combination of diabetes and neuropathy can cause an altered gait, increased tissue stiffness, limited joint mobility, muscle weakness, foot deformities, thus leading to excessive plantar pressure. The presence of an increased plantar pressure and the loss of sensation is a serious risk factor in the risk of development of diabetic foot ulcers (DFU). Therefore, appropriate shoes and insoles are recommended to redistribute high peak pressure (PP) and reduce pressure time integral (PTI) . Shoe modifications and insoles, when used, is effective to prevent the recurrence of plantar ulcer. The primary aim of the study was to: explore gait characteristics, kinetics and kinematics in a cohort of patients diagnosed with diabetes, with and without neuropathy, assigned to use different types of insoles. The second aim was to assess the relation between gait characteristics, kinetics and kinematics to high plantar PP and PTI. The third aim was to compare gait characteristics, kinetics and kinematics of patients with diabetes and healthy controls.

Start: January 2020

Treatment of Impending Ulcers Associated With Hammer, Mallet and Claw Toe Deformities in the Diabetic Patient Setting

Patients with diabetes, hammer, mallet and claw toes and impending ulcers associated with hammer mallet and claw toes will be randomized to tenotomy (cutting) of flexor tendons to the afflicted toes, done by needle and standard offloading or offloading alone. Impending ulcers are defined as callus or nail changes that are known pre-stages to ulcers. The effects of the surgery on incidence of ulcers associated with the named deformities, and rate of complications associated with the surgery.

Start: November 2019

Effect of Anesthesia Technique on Early Outcome in Diabetic Patients Undergoing Lower Extremity Amputation

The aim of this study was to compare early prognosis (mortality, morbidity) changes in concentrations of serum syndecan-1,partial pressure of oxygen(on arterial blood gas analysis), perioperative transfusion, intraoperative vasopressor use between general anesthesia and nerve block in diabetic patients undergoing limb amputation surgery as a prospective randomized trial.

Start: November 2019

Physical Activity Assessment of Patients With Diabetic Foot Wounds

The study evaluates the compliance of patients who suffer from a diabetic foot wound to follow a physical activity program, adapted to their medical condition. This study will aslo evaluate the security of this program, and how it could improve or not the quality of life, the diabet's metabolical balance, and the wounds's cicatrization speed.

Start: December 2020

Safety and Efficacy of ActiGraft Compared to Standard of Care in DFUs

The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers. The subjects are randomized to receive 1 of 2 treatments, either with ActiGraft and standard of care (SOC) or with SOC alone. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of the ActiGraft + SOC or SOC until for up to 12 weeks or until the study ulcer has completely healed (i.e., 100% closure as assessed by the Investigator and blinded assessor and confirmed 2 weeks later at the healing confirmation visit (HCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the ActiGraft arm or (2) change the standard of care dressing in the control arm. Immediately after the study ulcer is confirmed as completely healed, subjects will enter the 12-week Follow-up Phase. During the Follow-Up phase, subjects will be evaluated twice during the first month and then monthly for two additional visits every 4 weeks until the completion of the 12-week Follow-up Phase.

Start: December 2019

A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot

The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.

Start: September 2020

The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer

The study was planned as a prospective randomized controlled clinical trial to determine the effect of thermal evaluation in preventing diabetic foot ulcers in patients with Type II Diabetes Mellitus (DM).

Start: September 2020

Patient Empowerment Study

The Patient Empowerment Study is an observational longitudinal study among adults with diabetic foot ulcer (DFU). The scope of this study is to better understand how a patient's DFU disease process and usage of the Podimetrics System can impact patient health-related quality of life. Health-related quality of life will be measured by both the generic 36-item Short-Form Health Survey (SF-36) questionnaire and the ulcer-specific Diabetic Foot Ulcer Scale Short Form (DFS-SF) questionnaire.

Start: September 2020

Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

Patients who underwent surgery for diabetic foot were divided into three groups: sciatic nerve block (Group B), continuous nerve catheter (Group C) . Group B patients underwent preoperative popliteal ultrasound guided peripheral nerve blockage. 20 ml of 0.25% bupivacaine was administered. In Group C patients, 20% bupivacaine 20 ml was applied to the sciatic nerve with a peripheral nerve catheter and continuous infusion was started with patient controlled analgesia device.

Start: December 2019

Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus

The primary objective of this study is to compare the efficacy of standard treatment associated with a topical anti-staphylococcal bacteriophage cocktail versus standard treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface area (%) at 12 weeks.

Start: January 2021

Application of S26E for Diabetic Foot Ulcer Healing

A randomized, controlled open-label, parallel group study to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil for the healing of non-infected diabetic foot ulcers.

Start: May 2020

Diabetic Foot Ulcer Recurrence: Pilot Study

In this prospective pilot study, patients with DFU visiting the Ohio State University Comprehensive Wound Center will be enrolled. Patients enrolled in the study will be followed for 16 weeks for wound closure(Phase A), and will then begin Phase B where TEWL measurements and wound recurrence will be followed up for up to 12 weeks.

Start: January 2019

Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers

Diabetes mellitus (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. The DFU affect 15% of diabetic patients. Several studies have been conducted aiming to find therapeutic strategies for the healing of DFU, among the reported therapeutic methods the Low-level Laser Therapy (LLLT) has been highlighted. The aim of this study is to investigate the effects of different doses of LLLT in the treatment of DFU. Methods: This study is characterized as a double-blind randomized clinical trial (RCT), consisting of four groups, the control group will have only dressing and placebo LLLT application and the other three groups will have dressing and real LLLT GaAs 904 nm application. Expected outcomes: to elucidate the effects of different doses of LLLT GaAs 904 nm on the treatment of DFU, beyond to identify the most effective dose.

Start: August 2019

Plasma and Scarring of Diabetic Ulcers

Diabetic foot is defined by World Health Organization as a syndrome in which the presence of neuropathy, ischemia and infection cause tissue damage or ulcers from minor trauma. This condition can be controlled in its early stages with conservative treatment, which is effective in preventing infections and amputations. However, even with the new knowledge acquired and the development of new therapies, the specialist often faces wounds that do not improve despite the proper treatment, so therapies have been sought to help the healing of these Ulcers. Growing evidence suggests that healing of chronic diabetic foot ulcers depends on growth factors and that the therapeutic use of these in wounds has the potential to accelerate their healing in conjunction with wound care Conventional. This study evaluates the effect of plasma rich in autologous growth factors on healing chronic ulcers of diabetic origin. This is a randomized clinical trial that evaluates two study groups. Control group in which advanced weekly healing will be performed while the post-advanced healing study group will be performed the intradermal application of plasma rich in growth factors. These manoeuvres will be performed once a week for four weeks and at the end of the study the results in both groups will be checked. Both groups will also evaluate, frequency and intensity of pain, quality of life, histological changes in ulcers and metabolic evaluation

Start: June 2018

Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Total contact casts (TCCs) are effective treatment of plantar diabetic foot ulcers because they effectively offload the ulcer and are non-removable, resulting in high adherence to using the device. However, TCCs are not widely used in clinical practice because they negatively impact gait and daily activities. A new treatment concept was invented, sealed therapeutic shoe, where a shoe with a custom-made insole offloads the ulcer, and the shoe is rendered irremovable to be worn day and night, like a TCC. In this multicenter randomized controlled trial (RCT), 150 participants will be recruited and randomized to two treatment arms: TCC or sealed therapeutic shoe. The primary outcome is ulcer healing, secondary outcomes include (but are not limited to) skin complications, glycemic control, body mass index, gait function, balance, quality of life, physical activity, and health economics.

Start: August 2019

The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)

Rationale: Foot ulcers among diabetics are common. The presence of a contact allergy limits the healing process. Contact allergies for wound dressings are common among patients with ulcers caused by venous insufficiency but less is known about contact allergies in diabetic patients with ulcers. Objective: To determine the prevalence of contact allergies for wound dressings in patients with diabetic foot ulcers. Study design: A prospective multicenter study. Study population: Patients (n=139) with diabetic foot ulcers caused by type 1 or 2 diabetes mellitus treated at Rijnstate Hospital Arnhem, the Netherlands. Main study parameters/endpoints: The primary study parameter is the presence of contact allergies for wound dressings. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: An allergy test is standard procedure at Rijnstate Hospital, there is no direct technique-related burden or risk for the patient. In addition, wound dressings can be adjusted in patients where a contact allergy is determined which will benefit the prognosis of these patients. The data of this study will give insight in the prevalence of contact allergies for wound dressings in patients with diabetic foot ulcers.

Start: September 2019

Bioactive Split Thickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data as well as assess performance and safety of a commercially available human split thickness skin allograft with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds.

Start: August 2019

The Healing Effects Of Honey and Hydrogel Products On The Diabetic Foot

The Healing effects of Honey and Hydrogel Products on the Diabetic Foot. Abstract: Diabetes mellitus epidemiology is increasing dramatically affecting high numbers of the world's population, one of the highest risk consequences is diabetic foot and which might lead to leg amputation causing a permanent disability for the patient. Several studies had been conducted on the options available to treat diabetic foot ulcer, Honey products and Hydrogel stands out as an effective topical treatment for the foot ulceration. This study discusses the effectivity rate of these products and compares it with the classical methods followed to treat DF using topical and systematic antibiotics. Hence; our research raises the following questions: What is the effect of Honey and Hydrogel on the foot anatomy and physiology of DF patients? Could the investigators introduce a new protocol to treat DF using Honey and Hydrogel products? Aiming to achieve the following objects: To provide a new protocol to improve the anatomy and physiology of DF. To compare the efficacy of combined Hydrogel and Honey products on the diabetic foot ulcer. Reaching there the investigators are expecting to: To compare the healing time between the patients treated with hydrogel/honey products and the control treatment patients. To compare Lab parameters improvements between the patients treated with hydrogel/honey products and the control treatment patients. To compare neurological improvements between the patients treated with hydrogel/honey products and the control treatment patients. To compare the anatomical improvements between the patients treated with hydrogel/honey products and the control treatment patients. In order to provide a clear estimation for the safety and effectivity profile for each treatment method. Based on that the investigators are conducting using single blinded randomized clinical trial Suggesting the following Hypothesis: Treatment using topical MediHoney gel and/or Hydrogel together separately in association with empiric antibiotic regimens have a higher success rate comparing with treatment using topical and empiric antibiotic. A total of 140 DM patients from Outpatients DM type 2 will be included in this study, following up at diabetic foot center Al-Qaseem Saudi Arabia. Patients will be divided into 4 groups: st group will be treated with topical Medihoney product and empiric antibiotic. nd group will be treated with topical Hydrogel (purloin) gel and empiric antibiotic. rd group will be treated with a combination of Medihoney gel and Hydrogel (purloin) gel and empiric antibiotic. The 4th group will be treated with a combination of systematic and topical fucidin 1% antibiotic this group will be a controlled group. Based on the expected results the investigators are estimating that this study will raise the awareness of both health care personnel and the diabetic patients about this condition. It is expected to provide a clear efficacy estimation for each treatment method followed, facilitating the choice of treatment for physicians.

Start: September 2019

Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia

The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in patients with diabetes mellitus and critical limb ischemia.

Start: August 2018

A Real World, Observational Registry of Chronic Wounds and Ulcers

More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to transmit structured data on all patients followed with chronic wounds and ulcers (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and traumatic wounds). Data are collected at point of care including adherence to wound care quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).

Start: January 2005