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Diabetic Foot clinical trials

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NCT ID: NCT04817228 Completed - Diabetic Foot Ulcer Clinical Trials

A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers

Start date: April 21, 2021
Phase: Phase 2
Study type: Interventional

This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU). In addition, the pharmacology effect of EX-02 will be assessed. Lower leg ulcer size between 2 cm2 and 80 cm2 (surface area).

NCT ID: NCT04811989 Completed - Diabetes Mellitus Clinical Trials

Educational Interventions on Diabetic Foot Care

Start date: March 8, 2021
Phase: N/A
Study type: Interventional

Diabetes mellitus currently affects 463 million people worldwide. One of the most serious complications of diabetes is the diabetic foot. Adequate foot care behaviours reduce the risk of ulcers, infections, and amputations, and improve the quality of life, in these patients. This Pragmatic Randomized Controlled Trial aims to analyse the impact of different educational strategies - an instructive video (Video Watching Group - Experimental Group 1) compared with a leaflet on foot care with real-time guided reading (Real-Time Leaflet Reading Group - Experimental Group 2) and with standard teaching on diabetic foot care (Standard Care - Control Group) - on adherence and knowledge regarding diabetic foot care, as well as on patient's perception of their foot health. Participants will be assessed at the first consultation of the diabetic foot (T0), about two weeks after the first assessment (T1), and three months after the T0 in a follow-up assessment (T2), with T1 and T2 being performed through telephone calls, after obtaining the patients' consent. The results of the present study will inform educational interventions regarding foot care adherence in patients with diabetic foot, in order to decrease the likelihood of developing diabetic foot ulcers and, consequently, to reduce amputation rates and the several associated costs, contributing to improving patients' quality of life.

NCT ID: NCT04803708 Completed - Diabetic Foot Ulcer Clinical Trials

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

REVERSE
Start date: March 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers.

NCT ID: NCT04796649 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-03)

Start date: May 15, 2022
Phase: N/A
Study type: Interventional

The global prevalence of diabetes is on the rise and with it increase in prevalence of diabetic foot ulcers (DFU). These recalcitrant wounds are difficult to manage and pose a heavy economic burden. Photobiomodulation (low-level laser) is used for acceleration of wound healing. The current study is designed to evaluate the effectiveness of B-cure laser, a home-use low-level laser device, for acceleration of diabetic foot ulcer healing over standard treatment

NCT ID: NCT04795271 Enrolling by invitation - Diabetic Foot Clinical Trials

Biomechanical Study and Orthopedic Treatment Prevent in People With Diabetic Foot

FOOTprevent
Start date: November 12, 2020
Phase: N/A
Study type: Interventional

Spain is the country with the second-highest rate of population amputation due to the development of ulcers, behind the United States, where 2 out of 3 non-traumatic amputations derive from diabetes. This is why the main objective of this project is to establish a study protocol for alterations in plantar pressures and gait abnormalities in diabetic patients, parallel to the preventive orthopedic treatment of major complications such as Charcot's foot, ulcers in the plantar support surface, and amputations. The study methodology will be based on the evaluation prior to the personalized orthopedic treatment for each patient and the evaluation after the orthopedic treatment, specifically at one week, one month, three months, and six months after the treatment. At each evaluation time, plantar pressure and reaction forces during walking and local infrared thermography will be analyzed. In the basal and final evaluation at six months, the muscular strength and range of motion of the lower limbs will also be evaluated. The orthopedic intervention is personalized to the requirements of the patients and is based on the use of an insole with the possible inclusion of orthopedic footwear in order to reduce plantar pressure.

NCT ID: NCT04791449 Recruiting - Diabetic Foot Ulcer Clinical Trials

Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers

Start date: October 10, 2021
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT04769115 Completed - Diabetic Foot Ulcer Clinical Trials

A Predictive Technology for Prevention of Diabetic Foot Ulcers

Start date: February 24, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04755647 Completed - Diabetic Foot Ulcer Clinical Trials

Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers

Start date: February 23, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT04753294 Completed - Diabetic Foot Ulcer Clinical Trials

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

ASOLO-CW
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04750837 Completed - Clinical trials for Platelet Rich Plasma

Platelet Rich Plasma and Diabetic Foot Ulcer

Start date: January 16, 2020
Phase: Phase 2
Study type: Interventional

In chronic diabetic foot ulcer, if the conventional dressing fails, new therapeutic options such as recombinant human growth factors and bioengineered skin substitutes may be beneficial, but the cost is a limiting factor. Autologous platelet rich plasma is a cost-effective method that enhances wound healing by promoting the healing process by local release of growth factors.